Ebook PostmarketSurveillanceTraining (PSF-R0a V2)

Medical Device Postmarket Surveillance
(PMS) Program Implementation Training
PSF-R0a
092121
www.orielstat.com | 732.548.0600
About Oriel STAT A MATRIX
Whether you are planning to bring a new medical device to market, harmonize a quality system
across a global organization, or enhance your organization’s productivity, turn to Oriel STAT A
MATRIX to get the expert support you deserve.
Founded in 1968, Oriel STAT A MATRIX is the world’s leading consulting and training organization
dedicated to business process improvement, management systems, and quality and regulatory
compliance. We have consultants in 33 states and more than 20 countries, and our team has
assisted customers in more than 75 countries.
OUR LIFE SCIENCES PRACTICE SUPPORTS MEDICAL DEVICE MANUFACTURERS

ACROSS THE GLOBE WITH:
Global Regulatory Affairs

Our regulatory affairs services span the full device life cycle – from premarket through manufacturing
and postmarket – allowing manufacturers to get their medical devices to desired markets more
efficiently, while meeting compliance and business goals throughout the product’s life.
Quality Assurance
Our quality assurance services support quality system development, implementation, management,
and auditing to improve business results, address issues, and satisfy global medical device
requirements, including ISO 13485:2016, ISO 9001:2015, US FDA GMP Quality System Regulation
(QSR), the Medical Device Single Audit Program (MDSAP), and the EU MDR.
Performance Excellence
Our extensive experience with performance excellence methodologies like Process Management,
Lean and Six Sigma, teams, and Voice of the Customer enable our customers to identify and solve
tough business problems to improve performance and results – without compromising compliance.
Training
Thousands of companies have turned to us for their RA/QA training and we’ve trained over
130,000 quality system auditors. Our library includes courses on more than on 50 RA/QA-related
topics. Classes are offered in the US, Costa Rica, and the EU, or can be delivered on-site as is or
customized for your company.
For more information, visit us at www.orielstat.com or call us at 1.800.472.6477.

©2021 Oriel STAT A MATRIX. All rights reserved. This book is for the
use of the registered course participant only, and no part of it may be
reproduced, distributed, or transmitted in any form or by any means,
including photocopying, or other electronic or mechanical methods,
without the prior written permission of Oriel STAT A MATRIX.
Section 1:
Course Overview
SECTION 1: COURSE OVERVIEW
Objectives
Introduce Oriel STAT A MATRIX
Introduce the course
© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-2

Who Is Oriel STAT A MATRIX?

We’re a global consulting and training firm in RA/QA and
performance excellence for the medical device industry
TRAINING CONSULTING
91% of the largest device Address all phases of the product

manufacturers train with us life cycle, all device types
Courses cover 50 RA/QA topics, Consultants average 25 years of
ics
80 performance excellence topics e
experience
Trained 130,000+ auditors
50 YEARS OF EXPERIENCE GLOBAL REACH

Training
Founded in 1968 Customers in 75+ countries

Started working with US FDA Consultants in 20 countries
in 1977 and 33 states
Timeline
1968 STAT A MATRIX is founded. Focus is on quality systems development, quality audits, and process quality control and reliability.
1977 Chosen by US FDA to train their investigators in the new medical device regulation.
Trained 1,500 FDA investigators over a 12-month period and worked with FDA to refine the regulation.
1980 Medical device practice expands to include consulting for all phases of a device’s life cycle, from premarket to postmarket requirements.
1983 Oriel Inc. is founded (originally called Joiner Associates).
1988 Oriel, as Joiner Associates, publishes The Team Handbook™; more than 1.4 million copies have been sold to date.
1990 STAT A MATRIX becomes the first US-based company to offer IRCA-Registered Lead Auditor Training. We quickly become
the largest ISO 9000 (and later ISO 13485) training/consulting firm.
In the late 1990s, Oriel is instrumental in developing Lean Six Sigma training for GE, which goes on to become the gold
standard for Lean and Six Sigma training.
2001 STAT A MATRIX acquires Oriel, becomes Oriel STAT A MATRIX.
Introduction of sustainable performance management (SPM) – a methodology that integrates STAT A MATRIX’s
expertise in quality systems and regulatory conformance with Oriel’s performance excellence experience. Via SPM, our
customers achieve compliance with standards and regulations while making processes more effective and efficient, thus
improving business performance.
2014 Introduction of performance-based auditing methodology – an approach for auditing beyond compliance by analyzing process
performance.
TODAY Consulting – premarket, product realization, and postmarket

Training – 50 RA/QA topics, 80 performance excellence topics
Global presence
Innovative and flexible support options

Full Life-Cycle Support
Full Life-Cycle Support, Cont.
Full spectrum support: Oriel STAT A MATRIX offers a complete

spectrum of quality and regulatory training and consulting, ranging
from initial device classification and registration, quality system
development, software validation, and risk management to
postmarket surveillance
Deep industry experience: Our consultants / trainers average
25 years of industry and / or FDA experience
– They have participated in Working Groups that include ISO TCs for
ISO 9000, ISO 13485, ISO 14971, and ISO 14000; IEC 60601-1,
IEC TC62, IEC 62306, IEC TC87, IEC TC76, IEC SC62A, and
IEC SC62D; and ISO TC210, ISO TC215, and ISO TC245
Global reach: Oriel STAT A MATRIX is headquartered in Union, NJ
– We have consultants in 33 states and more than 20 countries
– We have assisted customers in more than 75 countries

Course Overview
Student Manual: Table of Contents
Section 1 Course Overview

Section 2 Quality Management System Requirements
Section 3 Global Postmarket Surveillance Requirements
Section 4 EU MDR and IVDR Changes Affecting
Postmarket Surveillance
Section 5 Postmarket Surveillance Planning, Data Collection,
Appraisal, and Analysis (Using ISO/TR 20416:2020)
Section 6 Postmarket Surveillance Reporting and Postmarket
Clinical Follow-Up
Section 7 Technical Documentation and PMS Linkages to
QMS Processes
Section 8 Successful PMS Audit Outcomes

Course Agenda
The course agenda is your roadmap to the course

– It outlines the course sections, specific section objectives,
exercises / workshops, and timeframes
Course Objectives
1. Clearly define postmarket surveillance in your organization,

and explain the purpose of the postmarket surveillance
process within the context of your quality and risk
management systems
2. Discuss in detail compliance with country-specific
postmarket surveillance regulatory requirements, including
the EU MDR and IVDR
3. Identify and build needed linkages between your
postmarket surveillance process and QMS and risk
management processes

Course Objectives, Cont.
4. Create a postmarket surveillance plan based on related

regulatory requirements and the ISO 13485:2016 and
ISO 14971:2019 standards
5. Use ISO/TR 20416:2020 guidance to establish a process
to identify, gather, assess, and analyze postmarket
surveillance data
6. Prepare a framework for postmarket surveillance reporting

Section 2:
Quality Management System Requirements
SECTION 2: QUALITY MANAGEMENT SYSTEM REQUIREMENTS
Learning Objectives
Clearly define postmarket surveillance in your organization

Explain the purpose of the postmarket surveillance
process within the context of your quality and risk
management systems

Defining Postmarket Surveillance
Postmarket Surveillance: FDA vs. EU
(under EU Medical Device
(under 21 CFR 822)
Regulation 2017/745)
Initiated after an FDA Initiated by the manufacturer
request for post-design as a proactive process to
control data obtained identify any need to
during clinical examinations immediately apply any
FDA will tell the company necessary corrective or
which data to submit preventive actions

Key Definitions for Postmarket Surveillance

21 CFR 822.3 (i) Postmarket surveillance means the active, systematic,
scientifically valid collection, analysis, and interpretation
of data or other information about a marketed device
(j) Prospective surveillance means that the subjects are
identified at the beginning of the surveillance and data or
other information will be collected from that time forward
(as opposed to retrospective surveillance)
EU Medical Proactive, systematic activities carried out by

Device manufacturers in cooperation with other economic
Regulation operators to collect and review experience gained from
(2017/745) their devices to identify any need to immediately apply
any necessary corrective or preventive actions
ISO Systematic process to collect and analyze experience

13485:2016 gained from medical devices that have been placed on
the market
Postmarket Surveillance Defined
A quality management system:

– Manages the interacting processes and resources required to
provide value and realize results for relevant interested parties
– Enables top management to optimize the use of resources
considering the long- and short-term consequences of
their decision
– Provides the means to identify actions to address intended and
unintended consequences in providing products and services
ISO 9000:2015, 2.2

Overview of Postmarket Surveillance Activities
Postmarket surveillance should include:

– Determining if changes must be made to the original risk
assessment for the device
– Using a systematic process to evaluate the product (not just
customer complaints)
– Including objective evidence in risk management
– Evaluating any new hazards
– Determining whether there have been changes in the acceptability
of risks as originally defined
– Including feedback and revisions of risk assessment / management
as required
– Links between systems, including CAPA, complaints, risk
management, and clinical evaluation
–
Potential Postmarket Surveillance Sources
This list is not exhaustive, but it provides examples of

areas to evaluate:
– Complaints
– Nonconformances
– Service reports
– Literature
– Total Product Life Cycle (TPLC) database
– Postmarket clinical follow-up studies
– Patient registries
– Customer surveys
– Social media
– Trade shows
– FDA Manufacture and User Device Experience (MAUDE) database

Who / What Requires Postmarket Surveillance?
ISO 13485 – Clause 8.2 Monitoring and Measurement

ISO 14971 – Clause 10 Production and post-production
activities
US FDA Quality System Regulation (21 CFR 822)
EU Medical Device Regulations Articles 83-86
EU IVDR Regulations Articles 78-87
Australian Therapeutic Goods (Medical Devices)
Regulations 2002 & Amendment 2010
Health Canada (SOR/98-282 61[2][c])
Who / What Requires Postmarket Surveillance?, Cont.
Japan MHLW Ordinance No. 169, updated by MHLW

ordinance No. 87 dated July 30, 2014 & MHLW Ordinance
No. 135
Brazil Resolution, including:
– RDC N. 67 Provisions regarding post-market surveillance
applicable to registration holders of health product in Brazil
– RDC 16/2013 GMP Requirements for Medical Devices and IVDs
All conformity assessment procedures (as well as medical

device quality systems) require the manufacturer to
maintain a postmarket surveillance (PMS) system
regardless of the classification of the medical device
Where Do I Start?
Organize a team that will manage postmarket activities

– The team may be comprised of representatives from multiple
functional areas of the business, including:
QA/RA
Manufacturing
Design
Field services
Sales
Technical support
Medical or clinical affairs
The structure of the teams will vary depending on:
– Size of the company
– Organizational structure
– Geographic locations
Who Is Responsible for Postmarket Surveillance?
Ultimately, everyone in the organization is responsible

for PMS
PMS is holistic and systematic; it is not the responsibility

of one unit or team

Quality Management System Basics
The Process-Based Model for the QMS (ISO 13485:2016)
8.2.4 Internal Audit
5
Management
8.2.1
Responsibility Feedback
8.2.2
Regulatory
Complaint
Authorities
8.3, 8.4, 8.5 Handling
6 4 Control nonconforming
ISO 13485 Resource QMS product
Analysis of data
8.2.3
Management
Improvement Reporting to
Regulatory
Authorities
INPUTS
7 OUTPUTS Products and
User needs Prod. Realization
Services
8.2.5, 8.2.6 Monitoring and Measurement

Process and Risk-Based Approach
to the QMS
Process Approach: Overview
The process approach includes designing the organization’s

processes to operate as an integrated and holistic system
– The management system integrates processes and measures to
deliver on objectives
– Processes set interrelated activities and checks to deliver outputs
– Procedures must detail tasks and controls to perform activities

Process Approach: Why Use?
Understanding and managing interrelated processes as

a system:
– Contributes to effectiveness and efficiency in achieving results
– Enables control of the interrelationships and interdependencies
among the processes, so that overall organizational performance
is enhanced
Applying the process approach in a QMS enables:
– Understanding and consistency in meeting requirements
– Consideration of processes in terms of added value
– Achievement of effective process performance
– Improvement of processes based on evaluation of data
and information
Process Approach: Relationship with Risk-Based Thinking
The process approach:

– Incorporates risk-based thinking: must address risks that may
impact objectives and results in the QMS
– Uses risk-based thinking throughout to:
Decide how risk is addressed in the process
Design processes to improve outputs and prevent undesirable results
Improve the effectiveness of the QMS
Maintain and manage a system that inherently addresses risk and
delivers on objectives
Put into place preventive controls to minimize negative effects, and to
make maximum use of opportunities as they arise

DISCUSSION: QMS-RELATED QUESTIONS
What are some examples of interrelated processes in

the quality management system?
Reflect on your QMS

̶ What processes interrelate with your postmarket
surveillance process?
̶ Explain how these interrelationships have
been established

QMS Requirements for ISO 13485
ISO 13485:2016
ISO 13485:2016 clauses related to postmarket surveillance:

– 8.2.1 Feedback
Gather information related to meeting customer requirements
Maintain records
References applicable regulatory requirements for postproduction activities
– 8.2.2 Complaint handling
Document procedures for timely complaint handling
Maintain records
– 8.2.3 Reporting to regulatory authorities
Document procedures for providing notification to the appropriate regulatory
authorities
Maintain records
– 8.5.1 Improvement
Postmarket surveillance

ISO 13485:2016 – Improvement
8.5 Improvement
8.5.1 General
The organization shall identify and implement any changes necessary
to ensure and maintain the continued suitability, adequacy and
effectiveness of the quality management system as well as medical
device safety and performance through the use of the quality policy,
quality objectives, audit results, postmarket surveillance, analysis of
data, corrective actions, preventive actions and management review.
(Emphasis added)

QMS Requirements for EU MDR
The EU MDR and Postmarket Considerations
In MDD, postmarket surveillance (PMS) was covered in a

few lines
EU MDR requirements place a much stronger emphasis
on PMS activities
The EU MDR:
– Emphasizes management of postmarket activities, especially
related to management of postmarket clinical follow-up (PMCF)
– Emphasizes relationships between clinical investigations
and PMCF
– Requires that information from clinical investigation and PMCF be
entered into the clinical evaluation report (CER)
– Requires organizations to have a defined, formal plan for handling
postmarket activities

EU MDR Postmarket Surveillance System
For each device or product family, the manufacturer

must develop PMS activities that address:
– Planning
– Establishing processes
– Documenting activities
– Implementing actions
– Maintaining processes and records
– Updating activities during review periods
The postmarket surveillance system must be
established proportionate to risk class and for type
of device
The system must be an integral part of the
manufacturer’s QMS
EU MDR QMS Requirements: Distributors and Importers
In the EU MDR, a QMS is not required by EU MDR

Articles 13-14, but it is the recommended way to meet
their general obligations:
– Distributors and importers should have procedures for handling
corrective actions
Complaint reporting during use of device
Vigilance reporting from users affected
Handling field safety corrective action (FSCA) notices
Communicating field safety notices (FSN) to users
– There must be communication with manufacturer(s) to inform
them of any corrective action (postmarket) taken
– Communication, monitoring, and assistance in ensuring that
devices placed on the market are safe
EU MDR Articles 13 and 14 cover general obligations of importers and distributors

QMS Requirements for EU IVDR
IVDR QMS Requirements: Postmarket Surveillance
Manufacturers must have a postmarket surveillance

system for each device
This system should:
– Be proportionate to the risk class of device
– Be appropriate for the type of device
– Be able to actively and systematically gather and analyze relevant
data throughout the device’s entire lifetime
– Allow the manufacturer to draw the necessary conclusions and to
determine the need for any preventive and corrective actions
The postmarket surveillance system is

an integral part of the manufacturer’s QMS
Article 10 (8)(i), (9), and Article 78 Post-market surveillance system of the manufacturer (1)

Roadmap for QMS Conformance
and Compliance
Roadmap for QMS Conformance
ISO 13485:
Implement a PMS system capable of gathering information
related to meeting customer requirements
As part of the PMS system, ensure procedures are in
place for timely complaint handling and reporting to
Regulatory Authorities
Document procedures for providing notification to the
appropriate Regulatory Authorities
Use data, including postmarket surveillance data, to
identify and implement any changes needed to ensure that
the QMS is effective and the device is safe and effective

Roadmap for QMS Compliance
EU MDR and IVDR:

Identify and document ISO 13485:2016 and
EU MDR, EU MDR, IVDR requirements
appropriate for the organization
Clearly define the scope of the QMS to include
these requirements
Establish the PMS system as an integral part of
the QMS
Link processes of the QMS as appropriate to the
PMS system
EXERCISE 2:1 DOCUMENT A PMS PROCESS
Refer to the Student Workbook for instructions

Section Summary: Student Workbook
Key points or What are 3-4 key points from this section?
takeaways
for section
Impact on your Is there an impact? If yes: High? Medium? Low?

organization Summarize the impact.
and / or your
job role
Next steps What does your team or organization need to do next to start
addressing this topic?

Section 3:
Global Postmarket Surveillance Requirements
SECTION 3: GLOBAL POSTMARKET SURVEILLANCE REQUIREMENTS
Learning Objectives
Discuss compliance with the adverse event and

postmarket surveillance regulatory requirements for:
– Australia
– Brazil
– Canada
– Japan
– US
– EU (MDR and IVDR)
© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0a 3-2

Global Postmarket Regulatory Requirements
Requirements Where Found

FDA 21 CFR 820.198: Complaint handling
21 CFR 820.100: Corrective and preventive action
21 CFR 803: Medical Device Reports (MDRs)
21 CFR 806: Corrections and removals
23 CFR 822: Postmarket surveillance
EU MEDDEV 2.12-1 Rev 8 – Guidelines on a medical

devices vigilance system – primary
Regulation (EU) 2017/745 of the European Parliament
Regulation (EU) 2017/746 of the European Parliament
Health Canada Guidance Document for Mandatory Problem Reporting

for Medical Devices
SOR/98-282 Canadian Medical Device Regulation (59)
Global Postmarket Regulatory Requirements, Cont.

Brazil RDC 185/2001 Classification and Registration
Requirements of Medical Products
RDC 16/2013 GMP Requirements for Medical Devices
and IVDs
Japan MHLW Ordinance No. 169, updated by MHLW

ordinance No. 87 dated July 30, 2014 & MHLW
Ordinance No. 135
Australia Australia Therapeutic Goods (Medical Devices)

Regulations 2002 & Amendment 2010

Global Postmarket Guidance and Standards

GHTF SG2/N54R8:2006 – Medical Devices Post Market
Surveillance: Global Guidance for Adverse Event
Reporting for Medical Devices
ISO 13485:2016 8.2.1: Feedback
8.2.2: Complaint handling
8.2.3: Reporting to regulatory authorities
8.3.3: Actions in response to nonconforming product
detected after delivery
8.4 Analysis of data
8.5.2: Corrective action
8.5.3: Preventive action
ISO 14971:2019 Application of Risk Management to Medical Devices,
Section 10 – Production and post-production activities
ISO TR 24971:2020 Section 10
ISO TR 20416:2020 Medical Devices – Post-Market Surveillance for
Manufacturers
Adverse Event Reporting in the Postmarket
Surveillance System
Global Adverse Event Reporting
One component of the postmarket surveillance system is

the reporting and trending of serious incidents and the
conduct of safety-related corrective actions
This reportability is referred to differently by different

Regulatory Bodies; for example:
– MDR: Medical Device Report (US)
– MPR: Mandatory Problem Report (Canada)
– MDV: Medical Device Vigilance (EU)
The requirements are common between organizations

Reportability and Reporting in Postmarket Surveillance
It is critical that the postmarket surveillance system supports

the reportability decisions and reporting processes for all
jurisdictions where the device is marketed
Keep in mind that what is reported in one jurisdiction may

not be reported in another
Also, some jurisdictions require reporting, even when the

incident did not occur there
Overview of Adverse Event Reporting
Event reporting
Report based
Yes on global
Determine
requirements;
if reporting is Reportable?
document
required
decision maker
and decision
No date
In the complaint file,
document the rationale,
decision maker, and
decision date

Australia Postmarket
Surveillance Requirements
Adverse Events and Advisories

PMS Regulatory Requirements: Australia
Regulation: Therapeutic Goods (Medical Devices)

Regulations 2002, Schedule 3 Part 1 Clause 1.4 (3) (C) (i)
Manufacturers are required to implement a postmarketing

system that includes provisions for adverse event reporting
Manufacturers must report events to the TGA (or to the

Sponsor) in a timely manner to ensure that the Sponsor
can meet their reporting obligations


PMS Regulatory Requirements: Australia, Cont.
Australian Sponsors of Class AIMD, Class III, and Implantable Class IIb
devices must provide three consecutive annual reports to the TGA after
inclusion of the device in the ARTG
The reports should include:
– ARTG number | Product name
– Model number(s)
– Number supplied in Australia and number supplied worldwide
– Number of complaints in Australia and number of complaints worldwide
– Number of adverse events and incident rates in Australia (rate = number of
events / number supplied x 100 = rate%)
– Number of adverse events and incident rates worldwide
– A list of the more common complaints and all of the adverse events
– Device Incident Report (DIR) number of adverse events reported to TGA
– Regulatory / corrective action / notification by manufacturer
MDSAP Audit Approach

PMS Regulatory Requirements: Australia, Cont.
Summary
– Manufacturers are required to implement a postmarketing
system that includes provisions for the recovery of devices
– Proposed recalls must be reported by the manufacturer to the
TGA, or to the Sponsor in a timely manner to ensure that a
Sponsor can meet their reporting obligations
– Note: Australian Sponsors are required to provide
manufacturers with any information that will assist the
manufacturer in complying with the obligations of a conformity
assessment procedure (e.g., information in relation to the
recovery of devices)

Medical Device Reporting: Australia
Medical Device Reporting Summary

Who Medical device manufacturers and Sponsors
What Report adverse events to the Therapeutic Goods Association

(TGA)
Must submit adverse events to the Medical Device Incident
Reporting (MDIR) System
Manufacturers must contact their Australian Sponsor when
vigilance reporting is necessary
• The Australian Sponsor will submit the adverse event to
the TGA on the manufacturer’s behalf when:
o A reportable adverse event has occurred
o A recall is necessary
The Therapeutic Goods Act of 1989 and Therapeutic Goods (Medical Devices) Regulations of 2002
Event Reporting Timelines: Australia
Australia
Trigger Event Time Frame

Report if the information relates to an event or other occurrence Within 48 hours after
that represents a serious threat to public health becoming aware of
event or occurrence
Report if the information relates to an event or other occurrence Within 10 days
that led to the death or a serious deterioration in the state of after becoming aware
health of a patient, a user of the device, or another person of event or occurrence
Report if the information relates to an event or other Within 30 days

occurrence, a recurrence of which might lead to the death or a after becoming aware
serious deterioration in the state of health of a patient, a user of of event or occurrence
the device, or another person
Not stated specifically, but presume no requirement to report incidents occurring in other
jurisdictions if the device is approved for sale in Australia
The Therapeutic Goods Act of 1989 and Therapeutic Goods (Medical Devices) Regulations of 2002

Brazil Postmarket

PMS Regulatory Requirements: Brazil
Regulation: RDC ANVISA 67/2009 – Art. 6º- PMS l
Manufacturers are required to establish and implement a postmarket

surveillance system that is integrated into the quality system
The postmarket surveillance system must ensure the:
– Correct and the prompt identification of adverse events
– Performance of investigations
– Use of the results to improve the safety and effectiveness of the device
when necessary
For domestic manufacturers (also applies to legal representatives in

Brazil): top management must designate a professional to be
responsible for the postmarket surveillance system
Source: MDSAP Audit Approach


PMS Regulatory Requirements: Brazil, Cont.
The organization must have:

– Mechanisms for processing and recording complaints, conducting
investigations, and providing feedback directly to the complainant
(for foreign manufacturers, to their legal representative in Brazil)
– Notified the Regulatory Authority about problems with their
devices, including adverse events (critical or noncritical), any
identified technical defect for products already marketed, anything
that can cause a serious hazard to public health, or counterfeiting
– For international manufacturers: The legal representative in Brazil
must be made aware about the occurrence of possibility of death,
serious hazard to public health, or counterfeiting associated with
their products exported to Brazil

Procedures and workflows must be established in order to

identify when field actions (recalls and corrections) are
necessary, in accordance with the organization’s
postmarket surveillance system and quality system
The organization keeps records regarding field actions
performed, including those that do not need to be reported
to Regulatory Authorities
The organization performs field actions based on potential
or concrete evidence that their product does not comply
with essential requirements of safety and effectiveness


For domestic manufacturers (also applies to legal

representatives in Brazil), the organization:
– Sends to the Regulatory Authority requested reports
– Performs field actions when required by the Regulatory Authority
– Notifies the Regulatory Authority regarding field actions
For international manufacturers: Make the legal

representative in Brazil aware of the field actions
performed on products exported to Brazil
Medical Device Reporting: Brazil
Brazil Medical Device Reporting Summary
Who The device manufacturer and Brazil Registration Holder
What Report adverse events to the National Sanitary Surveillance

System (SNVS)
A technical complaint must also be reported under certain
circumstances if a reoccurrence could lead to a severe
adverse event
Brazil Resolution RDC No. 67/2009 and Resolution RDC No. 23/2012

Event Reporting Timelines: Brazil
Brazil
Report death, serious threat to public health, or falsification occurring Within 72 hours
in Brazil
Report severe adverse event without associated death; report Within 10 days
nonserious adverse event if recurrence has potential to cause a
severe adverse event to a patient, user, or other person
Report events with potential for severe adverse events if the Within 30 days
occurrence is not remote or has already caused / contributed to death
or serious harm to health in the last two years; report if there is a need
for a health hazard evaluation or there is evidence of misuse due to
poor instructions
Report incidents (death, serious threat to public health, or falsification) Within 10 days
occurring in other jurisdictions if the device is approved for sale in
Brazil and affected serial numbers and lots were imported into Brazil
Resolution RDC No. 67/2009 and Resolution RDC No. 23/2012

Health Canada Postmarket

PMS Regulatory Requirements: Canada
MDSAP Chapter 4, Task 1 includes reporting related to

incidents occurring inside or outside Canada involving a
device sold in Canada
– Note: If the incident reports are submitted to the Minister just by

the Importer, verify that the manufacturer has advised the Minister
in writing that the reports the manufacturer and importer would
have submitted were identical and that the manufacturer has
permitted the importer to prepare and submit reports to the
Minister on the manufacturer’s behalf


PMS Regulatory Requirements: Canada, Cont.
MDSAP Chapter 4, Task 2 includes information to report

before undertaking a recall
– Note: If recall reports are submitted to the Minister just by the

Importer, verify that the manufacturer has advised the Minister in
writing that the reports the manufacturer and importer would have
submitted were identical and that the manufacturer has permitted
the importer to prepare and submit reports to the Minister on the
manufacturer’s behalf
Incident Reporting: Inside Canada

(Effective June 23, 2021)
Incident Reporting Summary: Inside Canada

Who Both the manufacturer and the importer of a medical device
What Make a preliminary and a final report for any incident that comes to
their attention occurring in Canada that involves the device if:
The device is sold in Canada, and
The incident relates to a failure of the device or a deterioration in
its effectiveness or any inadequacy in its labelling or in its
directions for use, and
Has led to the death or a serious deterioration in the state of
health of a patient, user or other person, or could do so if it were
to recur
CMDR Incident Reporting 59 (1-2) Effective June 23, 2021

Incident Reporting: Outside Canada

(Effective June 23, 2021)
Incident Reporting Summary: Outside Canada

What For incidents occurring outside Canada:
For Class I devices: The manufacturer and the importer of a
shall each make a preliminary and a final report concerning any
incident that comes to their attention occurring outside Canada
that involves the device if the incident:
• Relates to a failure of the device or a deterioration in its effectiveness
or any inadequacy in its labelling or in its directions for use; and
• Has led to the death or a serious deterioration in the state of health
of a patient, user or other person, or could do so if it were to recur
* Requirement to report incident outside Canada only applies to Class I devices and
does not apply unless the manufacturer has indicated to a regulatory agency of the
country where the incident occurred that the manufacturer will take corrective action, or
unless the regulatory agency has required the manufacturer to take corrective action
CMDR Incident Reporting 59 (1-2) Effective June 23, 2021; Incident reporting for medical devices: Guidance document, Effective June 23, 2021
Incident Reporting: Outside Canada

(Effective June 23, 2021), Cont.
Incident Reporting Summary: Outside Canada, Cont.

What For Class II-IV devices: Must notify Health Canada when there’s
a serious risk of injury to human health concerning a device
authorized for sale in Canada and when:
• a notifiable action* is taken by a foreign regulator of a certain
jurisdiction** or
• the license holder and importer take notifiable actions in certain
foreign jurisdictions
*“Notifiable action: An action taken in one of the specified jurisdictions relating to the
safety of a medical device for the purpose of mitigating or eliminating a serious risk of
injury to human health. Notifiable actions include risk communications, recalls, label
changes, reassessments, suspensions or revocations of authorization to prevent serious
risk of injury to human health. An action relating to the medical device may include
issues regarding the quality, effectiveness or performance characteristics of the medical
device, if safety was impacted.”
**Canada maintains a list of regulatory agencies and foreign jurisdictions that apply
CMDR Incident Reporting 59 (1-2) Effective June 23, 2021; Incident reporting for medical devices: Guidance document, Effective June 23, 2021; **List of
regulatory agencies and foreign jurisdictions https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-
canada/foreign-risk-notification-medical-devices-guidance/list.html

Incident Reporting Time Frames
For incidents occurring in Canada

Become aware of death or serious Submit report to Health Canada
deterioration in health of the patient, user, within 10 calendar days
or other person has occurred
Become aware of death or serious Submit report to Health Canada
deterioration in health did not occur as a as soon as possible, within 30
result of the incident but might if the calendar days
incident were to recur
After becoming aware of a potentially Reporter should submit a report
reportable incident, there is uncertainty within the time frame required for
about whether it is reportable that type of incident
Incident reporting for medical devices: Guidance document, Effective June 23, 2021
Foreign Reporting Time Frames
For incidents occurring outside Canada

When the decision has been Preliminary report be submitted as soon as possible
made to report a foreign after the manufacturer has informed the foreign
incident involving a Class I regulatory agency of the intention to take corrective
device action, or, as soon as possible after the foreign
regulatory agency has required the manufacturer to
take corrective action
Note: Health Canada interprets “as soon as possible”

to mean within 48 hours after the decision
Foreign Risk Notification (FRN) FRN must be provided within 72 hours of when the
for Class II to IV devices manufacturer or importer receives or becomes aware
of a notifiable action
Incident reporting for medical devices: Guidance document, Effective June 2021; Foreign risk notification for medical devices guidance document, January 2021

Japan Postmarket

PMS Regulatory Requirements: Japan
Regulation: Ordinance for Enforcement of PMD Act Article 228-20.2

to the Marketing Authorization Holder [MHLW MO169: 62.6]
Marketing Authorization Holders must implement postmarket safety

activities in accordance with Japanese regulatory requirements in addition
to the QMS requirements
The persons operating the registered manufacturing sites must report any
adverse event that meets specified criteria to the Marketing Authorization
Holder in a timely manner
The registered manufacturing sites are not required to report any adverse
event directly to a Regulatory Authority


PMS Regulatory Requirements: Japan, Cont.
Reportable events
– Malfunction events that may cause or may have caused
health damage:
Serious event (domestic and foreign)
Unlabeled non-serious event (domestic)
– Adverse reaction events that were caused or might have

been caused by the malfunction of a medical device
Serious event (domestic and foreign)
Unlabeled non-serious event (domestic)

Reportable events, cont.

– Actions taken to prevent the occurrence or expansion of a public
health hazard in relation to a medical device that is marketed in
foreign countries and is equivalent to the one marketed in Japan,
including (but not limited to):
Suspension of manufacturing, importing, or selling
Recall
Abolishment


Reportable events, cont.

– Study report that indicates:
Possibility of cancer and other serious illness, injury, or death
caused by malfunction of a medical device (domestic and
foreign), or by infectious disease arising from usage of a device
(domestic and foreign)
Significant occurrence rate change of event, etc., caused by
malfunction of a medical device (domestic and foreign)
Significant occurrence rate change of infectious disease caused
by usage of a medical device (domestic and foreign)
If a medical device proves to be less effective than claimed
when approved

Marketing Authorization Holders are required to report advisory

notices to Regulatory Authorities (PMD Act 68-11)
The person operating the registered manufacturing site determines
and implements an effective arrangement for communicating with the
Marketing Authorization Holder in relation to advisory notices (MHLW
MO169: 29)
– Note: Persons operating registered manufacturing sites are not required to report
any advisory notice directly to a Regulatory Authority, but shall communicate with
the Marketing Authorization Holder so they can take necessary regulatory actions

Medical Device Reporting: Japan
Japan Medical Device Reporting Summary

Who Marketing Authorization Holders (MAHs) are required to report
advisory notices to Regulatory Authorities
The person operating a registered manufacturing site must
report to the MAH in a timely manner any adverse event that
meets specified criteria
• The registered manufacturing sites are not required to
report any adverse event directly to a Regulatory Authority
What Malfunction events that may cause or may have caused

health damage:
• Serious event (domestic and foreign)
• Unlabeled non-serious event (domestic)
Continues on next slide
Medical Device Reporting: Japan, Cont.
Japan Medical Device Reporting Summary, Cont.

What, Adverse reaction events that were caused or might have been
Cont. caused by the malfunction of a medical device
• Serious event (domestic and foreign)
• Unlabeled non-serious event (domestic)
Actions taken to prevent the occurrence or expansion of a
public health hazard in relation to a medical device that is
marketed in foreign countries and is equivalent to the one
marketed in Japan, including (but not limited to):
• Suspension of manufacturing, importing, or selling
• Recall
• Abolishment
Continues on next slide

Medical Device Reporting: Japan, Cont.
Japan Medical Device Reporting Summary, Cont.

What, Study report results that indicate:
Cont. • Possibility of cancer and other serious illness, injury, or
death caused by malfunction of a medical device (domestic
and foreign), or by infectious disease arising from usage of
a device (domestic and foreign)
• Significant occurrence rate change of event, etc., caused
by malfunction of a medical device (domestic and foreign)
• Significant occurrence rate change of infectious disease
caused by usage of a medical device (domestic and
foreign)
• The fact that a medical device is less effective than it was
claimed to be when approved
Event Reporting Timelines: Japan
Japan

Deaths Within 15 days of awareness
Malfunction, breakage, faults that could
lead to serious events that are anticipated
and trend is increasing
Serious events that are unanticipated Within 30 days of awareness

Serious events that are anticipated, but
trend is flat
Nonserious incidents Annually

Incidents occurring in other jurisdictions No requirement to report incidents
occurring in other jurisdictions if the
device is approved for sale in Japan

United States Postmarket
Overview of Device Regulation in the US
Key Entity FDA

US Overview
Device event 21 CFR 803 Medical Device Reporting Regulation

reporting 21 CFR 820.198 Complaints
21 CFR 806, Medical Devices; Reports of Corrections
and Removals
21 CFR 822 Postmarket Surveillance
¾ Initiated after an FDA request for post-design control data
obtained during clinical examinations – FDA will tell the
company which data to submit

FDA Requirements: 21 CFR 822
21 CFR 822
Applicable to Class II and Class III devices that meet any
of the following criteria:
– Failure of the device would be reasonably likely to have serious
adverse health consequences
– The device is intended to be implanted in the human body for
more than 1 year
– The device is intended to be used outside a user facility to support
or sustain life
If you fail to comply with requirements that ordered under section 522
of the act and this part, your device is considered misbranded under
section 502(t)(3) of the act and you are in violation of section
301(q)(1)(C) of the act
21 CFR 822
FDA Requirements: Postmarket Surveillance Order
FDA Postmarket Surveillance Order

A letter from FDA notifying a company of the requirement
to conduct postmarket surveillance
Use is prompted based on the identification of a
surveillance question during the review of the marketing
application for the device, as the device goes to market, or
after the device has been marketed for a period of time
Submit a plan to conduct postmarket surveillance

within 30 days of the date of receipt of the postmarket
surveillance order

Postmarket Surveillance Plan: FDA Responses
If the plan: FDA will send: Company must:

Should result in the collection of An approval order that Conduct postmarket surveillance of the
useful data that will address the identifies any specific device according to the approved plan
postmarket surveillance data collection activities
question related to the PMS
Should result in the collection of An approvable letter Revise the postmarket surveillance
useful data that will address the that identifies the submission to address the concerns in
postmarket surveillance specific revisions or the approvable letter and submit it to
question after specific revisions information that must FDA within the specified time frame (FDA
are made or specific information be submitted before the determines time frame case by case)
is provided plan can be approved
Does not meet the requirements A letter disapproving Revise the postmarket surveillance
the plan that identifies submission and submit it to FDA within
the reasons for the specified time frame (FDA
disapproval determines time frame case by case)
Is not likely to result in the A letter disapproving Revise the postmarket surveillance
collection of useful data that will the plan that identifies submission and submit it to FDA within
address the postmarket the reasons for the specified time frame (FDA
surveillance question disapproval determines time frame case by case)
For the guidance document “Postmarketing Safety Reporting for Combination Products” see https://www.fda.gov/media/111788/download
MDSAP
Additional Regulatory Requirements: US

(FDA): 21 CFR 803: Medical Device Reporting
Summary:
The manufacturer develops a process for reporting to FDA incidents
involving device-related deaths, serious injuries, and reportable
malfunctions that occur within and outside the United States if the same or
similar device is marketed to the United States
The manufacturer develops, maintains, and implements written medical

device reporting (MDR) procedures


PMS Regulatory Requirements: US
Regulation: (FDA): 21 CFR 803: Medical Device Reporting
The manufacturer’s MDR files contain the following:

– Information (or references to information) related to the adverse
event, including all documentation of deliberations and decision-
making processes used to determine if a device-related death,
serious injury, or malfunction was or was not reportable to FDA
– Copies of all MDR forms and other information related to the event
submitted to FDA

PMS Regulatory Requirements: US, Cont.
Regulation: (FDA): 21 CFR 803: Medical Device

Reporting, Cont.
The manufacturer submits reports to FDA no later than
5 working days after the day that the manufacturer
becomes aware of specified events
The manufacturer submits supplemental reports within
one month of obtaining information that was not
submitted in an initial report
Medical device reports include the unique device
identifier (UDI) that appears on the device label or on
the device package


PMS Regulatory Requirements: US, Cont.
Regulation: 21 CFR 806 – Medical Devices; Reports of

Corrections and Removals
The manufacturer has a process in place to notify FDA in

the event of actions concerning device corrections and
removals and to maintain records of those corrections
and removals
Medical Device Reporting: US 21 CFR 803
US Medical Device Reporting 21 CFR Part 803 Summary

Purpose Provides a mechanism for FDA and manufacturers to
identify and monitor significant adverse events involving
marketed medical devices
Who Device user facilities, manufacturers, and importers
When If device may have caused or contributed to a death or

serious injury
Malfunctions that could cause death / serious injury are
reported

Medical Device Reporting: US, Cont.
US Medical Device Reporting Summary, Cont.

What Develop and implement written MDR procedures
(21 CFR 803.17)
Conduct a complete investigation of each event

(21 CFR 820.198 Complaint handling)
Include all required information

(21 CFR 803.52 Manufacturer reporting requirements)
Establish and maintain MDR event files

(21 CFR 803.18 Requirements for establishing and
maintaining applicable MDR files or records)
Have a system in place that ensures access to information

that facilitates timely follow-up / inspection by FDA
Complaints and Reporting: US 21 CFR 198
Complaints: US FDA 21 CFR 820.198(a) Summary

Who Manufacturers
What Maintain complaint files

Establish and maintain procedures for receiving, reviewing, and
evaluating complaints by a formally designated unit
• Process complaints in a uniform and timely manner
• Document oral complaints are documented upon receipt
• Evaluate complaints to determine whether they
represent an event that must be reported to FDA under
part 803 (medical device reporting)

Complaints and Reporting: US, Cont.
Complaints: US FDA 21 CFR 820.198(d-e) Summary

What, If a complaint is an event that must be reported to FDA under
Cont. part 803, a designated person must promptly review, evaluate,
and investigate
• Maintain in a separate portion of the complaint files or
otherwise clearly identify it
Include in records of complaint investigations a determination of:

• Did the device failed to meet specifications?
• Was the device being used for treatment or diagnosis?
• What relationship, if any, is there of the device to the
reported incident or adverse event?
Event Reporting Timelines: US
US

Events that require remedial action to Within 5 working days of becoming
prevent an unreasonable risk of substantial aware
harm
Deaths, serious injuries, malfunctions Within 30 calendar days of becoming

aware
Adverse events occurring outside the US Within 30 calendar days of becoming

and device is sold in US aware

Corrections and Removals: US 21 CFR 806
Medical Devices; Reports of Corrections and Removals

21 CFR 806 Summary
Who Manufacturers and importers
What Submit written report to FDA of any correction or removal of a

device if done to:
• Reduce a risk to health posed by the device
• Remedy a violation of the act caused by the device that may
present a risk to health
o Unless already provided the information under 21 CFR 803
Submit the report within 10 working days of initiating the

correction or removal

EU MDR and IVDR Vigilance Reporting
EU MDR and IVDR Vigilance Reporting: Serious Incidents

and Field Safety
Except for investigational devices, manufacturers must report to the
relevant Competent Authorities any:
Serious incidents Except for expected side effects that are documented in product
involving devices made information, quantified in technical documentation, and subject
available in the to trend reporting
EU market If the incident occurs outside the EU, there is no requirement to
report it in the EU – even if the device is marketed in the EU
Field safety corrective Includes any field safety corrective action undertaken in
actions for devices made countries outside Europe for devices legally made available in
available in the EU market the EU market
for which actions have Only if the reason for the field safety corrective action is not
been taken limited to the device made available in countries outside
the EU
Submit reports to the electronic system for vigilance and postmarket surveillance
Expect MEDDEV 2.12/1 to be updated in the future

to align with new EU MDR requirements Vigilance
EU MDR Article 87

EU MDR and IVDR Vigilance Reporting: Timelines Overview
Overview of vigilance report timing

General rule The time period for reporting shall take account of the
incident’s severity
Report is incomplete To ensure timely reporting, the manufacturer may
submit an incomplete initial report and follow up with a
complete report
Uncertain if the If uncertain whether the incident is reportable, the
incident is reportable? manufacturer must still submit a report within the
required time period
Field safety corrective The manufacturer must, without undue delay, report
actions field safety corrective actions before undertaking them
Except in urgent cases when the manufacturer
needs to take corrective action immediately to
protect the safety of the public
EU MDR Article 87
EU MDR and IVDR Vigilance Reporting: Timelines

When to report:
Any serious incident Immediately after the manufacturer has established
the causal relationship* with its device or that such
causal relationship is reasonably possible, and
not later than 15 days after the manufacturer has
become aware of the serious incident
In the event of a serious public Immediately, and not later than 2 days, after the
health threat manufacturer becomes aware of this threat
In the event of death or Immediately after the manufacturer establishes or as

an unanticipated soon as it suspects a causal relationship* between the
serious deterioration in device and the serious incident, but not later than 10
a person’s state of health days after the date on which the manufacturer
becomes aware of the serious incident
* “Causal relationship” = how the device may have contributed or

EU MDR Article 87
contribute in the future to an event against a patient’s health and safety

EU MDR and IVDR Vigilance Reporting:

Periodic Summary Reports
The manufacturer may provide periodic summary reports instead of individual

serious incident reports
There can be similar For which the root cause has been identified
serious incidents that OR
occur with the same For which a field safety corrective action has
device / device type been taken
and: OR
Where the incidents are common and well
documented
Conditions apply! The coordinating Competent Authority must have

agreed with the manufacturer
Vigilance reporting has specified format, content, and frequency of the periodic
summary reporting to the authorities
EU MDR Article 87(9)

Competent Authorities
Competent Authorities shall record centrally, at the

national level, reports they receive from healthcare
professionals, users, and patients
Healthcare professionals monitor actions or incidents with
medical devices
Patients and users interacting with devices can report
issues or concerns to a central location
Note: Member States will be taking “appropriate measures” –

such as targeted information campaigns – to encourage
healthcare professionals, users, and patients to report
suspected serious incidents to the Competent Authorities

EXERCISE 3-1: ASSESS A PMS PROCESS
Section Summary
Key points or
takeaways
for section
Impact on your
organization
and / or your
job role
Next steps

Section 4:
EU MDR and IVDR Changes Affecting
SECTION 4: EU MDR AND IVDR CHANGES AFFECTING POSTMARKET SURVEILLANCE
Learning Objectives
Identify the changes in the EU MDR and IVDR that affect

Assess a postmarket surveillance system to identify gaps
based on the EU MDR and IVDR requirements
Identify gaps in an existing EU MDR and / or IVDR PMS
plan according to their requirements
Begin building a postmarket surveillance plan based on a
given device

EU MDR Changes Impacting
The EU MDR and IVDR Postmarket Focus
Remember that in MDD and IVDD, postmarket

surveillance (PMS) was not a major area of focus
Current focus of:
– 18 articles in each of the regulations dedicated to PMS
EU IVDR: Articles 78-95
EU MDR: Articles 83-100
– 1 full, separate annex to outline PMS technical documentation
requirements (Annex III for each)
– Dozens of references to postmarket surveillance in the
regulations, outside of the specific PMS articles and annexes
EU IVDR: 49 references
EU MDR: 53 references

The EU MDR and IVDR Postmarket Focus, Cont.
In addition, both regulations have articles and annexes

with information about postmarket clinical follow-up
(PMCF)
Both regulations require PMS to be an integral, linked part

of the quality management system
The expectation is that PMS is a proactive, systematic

process for gaining understanding of the device safety
and performance
Role of Eudamed as an Electronic System

EU MDR Entities and Roles
with PMS Responsibilities
Supply Chain Impact on Postmarket Surveillance

The EU MDR and IVDR expand responsibilities and obligations for economic
operators, many of which include PMS responsibilities:
Manufacturers • Premarket classification

• Postmarket surveillance
• Agreements with all entities
• Review of activities in distribution chain
• Registration
Authorized • Regulatory liaison with Competent Authorities (CAs)
Representatives • Liability for devices
• Compliance for devices on market
• Communication of vigilance
• Registration (when applicable)
Importers • Product traceability (UDI)
• Handling of product
• Registration (when applicable)
Distributors • Recalls and advisory notices
• Full product traceability (UDI)
• Customer complaints

New Role: PRRC
Person(s) Responsible for Regulatory Compliance (PRRC)

Summary:
Must have expertise in medical devices (EU MDR) or in vitro
devices (EU IVDR); duties include ensuring that:
• Device conformity is checked before release
• Technical documentation and the EU Declaration of Conformity
are drawn up and kept current
• Postmarket surveillance obligations are met
• Vigilance reporting obligations are fulfilled
• For investigational (EU MDR) or interventional (EU IVDR) devices,
issue a signed statement of conformity to GSPRs
EU MDR and IVDR Article 15
Responsibility of the Competent Authority
Market surveillance “[M]eans the activities carried out and measures taken
EU MDR Article 2(61) by competent authorities to check and ensure that
devices comply with the requirements set out in the
relevant Union harmonisation legislation and do not
endanger health, safety or any other aspect of public
interest protection”

Overview of EU MDR, IVDR Changes: QMS Impact

Summary of Requirement What’s New?
MDR and IVDR require Distributors and importers
implementation of a should have a QMS in place
comprehensive QMS Stronger emphasis on overall
The QMS must address: QMS implementation
– Clinical evaluation (EU MDR) UDI requirements
– Performance evaluation (IVDR)
Focus on postmarket
– Verification of UDI assignments
surveillance process (PMS)
– Implementation and maintenance
of a PMS system
Linkages to ISO 13485:2016

Mainly all components of the standard, including scope and application
Postmarket activities, including complaints: sections 8.2, 8.2.2, 8.5.2
UDI and traceability: sections 4.2.3, 7.5.8, 7.5.9
Overview of EU MDR, IVDR Changes:

Technical Documentation

Technical file is no longer a Introduction of concept of
“technical file” – broader technical documentation
scope now Technical documentation covers
Technical documentation by device all aspects of product realization
or device family and the entire life cycle
Replacement of Essential PMS-specific technical
Requirements in Annex I documentation requirements
Managing changes to technical listed in Annex III
documentation over life cycle Annex I is now General Safety
and Performance Requirements
Generation of technical documentation: sections 4.2.1, 4.2.3, 4.2.4, 7.5
Meeting GSPR requirements: sections 5.4, 7.1, 7.3, 7.5, 8.5
Maintaining documentation for device: sections 4.2.3, 4.2.5, 7.1, 7.5

Clinical and Performance Evaluation

Stronger linkage of clinical Strong focus on device risk
(EU MDR) and performance management activities
(EU IVDR) evaluation to risk Update clinical / performance
management evaluation throughout life cycle of
Plan, conduct, and document device
clinical / performance evaluation
Strong emphasis on postmarket
to GSPR
surveillance activities
Clinical / performance evaluation
linked to life cycle of device Vigilance reports are made to
an electronic system
Management of clinical / performance evaluation: sections 4.2.3, 5.4,
7.1, 7.2, 7.5, 8.2
Risk management activities: sections 4.1, 5.4, 7.1, 7.3, 7.5, 8.2, 8.5
Reporting vigilance actions: sections 7.2, 7.2.3, 8.2.2, 8.2.3, 8.5.2

Postmarket Requirements
Postmarket surveillance PMS planning and

(PMS) system implementation of PMS system
PMS system is part of technical Submission of periodic safety
documentation of product update reports (PSURs)
Reporting of safety characteristics PMS and vigilance reports made
of devices on the market to an electronic system
Reporting in Eudamed system Trend reporting of product
throughout entire life cycle
Postmarket surveillance system: sections 7.2.3, 8.2.1, 8.2.2, 8.3.3

Reporting to agencies on vigilance: sections 7.2.3, 8.2.2, 8.2.3, 8.3.3, 8.5
Trend reporting of product: sections 8.1, 8.2.5, 8.2.6, 8.3, 8.4, 8.5


Notified Body Impact
Reinforces responsibilities of Responsibilities of Notified

Notified Bodies Bodies clearly defined
Strengthens relationship Staff requirements for
with manufacturers Notified Body
Requires more in-depth Notify expert committee for
surveillance assessments to high-risk and novel devices
be performed, based on results of
postmarket surveillance Participation with MDCG and
expert panels on reviews
Uses unannounced audits

Auditing of the QMS for all applicable components and
surveillance audits
Competency and qualifications: sections 5.5.1, 5.5.2, 6.1, 6.2
DISCUSSION: IDENTIFY CHANGES THAT

IMPACT PMS
What are the EU MDR / IVDR changes impacting PMS

that will most affect your organization?
How will you adjust your system to the changes?

Building the PMS System
Why the Focus on EU MDR and IVDR?
Under the EU MDR and IVDR:

– Requirements for postmarket surveillance are specific and detailed
– Postmarket surveillance structure can be adjusted and
supplemented to meet and enhance PMS requirements
wherever a manufacturer markets
– The postmarket system is comprehensive and covers all potential
aspects of a PMS system:
Vigilance reporting
Integrations with clinical and risk management
Trend reporting
Postmarket data analysis
Reporting of PMS data to Regulatory Authorities
Field safety corrective actions
Proactive PMS data gathering

Why the Focus on EU MDR and IVDR?, Cont.
Organizations that structure their PMS system according

to the requirements of the EU MDR and IVDR are finding
that they have a better understanding of:
– Performance and safety of the device
– Previously unidentified hazards
– Device use in the field
– Benefits of the device in relation to the risks associated with
device use
– Conformance to safety and performance requirements in
multiple regulations
The recommendations for a postmarket surveillance system and PMS plan in

the remaining portion of this section are based on the requirements found in the
EU MDR and IVDR; however, they can provide a base for any PMS system
Postmarket Surveillance System
For each device or product family, the manufacturer

develops PMS activities that address:
– Planning
– Establishing processes
– Documenting activities
– Implementing actions
– Maintaining processes and records
– Updating activities during review periods
The postmarket surveillance system established is
proportionate to risk class and for type of device
The system must be an integral part of the
manufacturer’s QMS

Postmarket Surveillance System: Purpose
The postmarket surveillance system is suitable for:

– Actively and systematically gathering, recording, and analyzing
relevant data on quality, performance, and safety of device
– Conducted in accordance with documented methods
– Obtaining data for a device throughout its entire life cycle
– Drawing the necessary conclusions for actions to take
– Determining, implementing, and monitoring any preventive and
corrective actions
– Interacting and driving updates to other QMS processes
– Producing PMS data for assessment at management review
Overview of Postmarket Surveillance Activities
Postmarket surveillance should include:

– Determining if changes must be made to the original risk
assessment for the device
– Using a systematic process to evaluate the product (not just
customer complaints)
– Including objective evidence in risk management
– Evaluating any new hazards
– Determining whether there have been changes in the acceptability
of risks as originally defined
– Including feedback and revisions of risk assessment /
management as required
– Links between systems including CAPA, complaints, risk
management, and clinical evaluation
–

Postmarket Surveillance System: Data Use
Manufacturers use the data from the postmarket

surveillance system to:
– Update benefit-risk determination and improve risk management
– Update design and manufacturing information, instructions for use,
and labeling
– Update clinical evaluation
– Update summary of safety and clinical performance, as applicable
– Identify needs for preventive, corrective, or field safety corrective
action in the market
– Identify options to improve usability, performance, and safety
– Contribute to postmarket surveillance of other devices, when relevant
– Detect and report trends of defined periods
Note: Update technical documentation when needed
Corrective and Preventive Action
If the PMS identifies a need for preventive or corrective

action (or both), the manufacturer:
– Implements the appropriate measures
– Informs the relevant regulatory bodies concerned
– Informs the organization’s Notified Body, as required
– Also reports any serious incidents or field safety corrective actions
Establish a procedure and process for reporting
Create reporting decision trees, based on where the action is occurring

Responsibilities and Authorities for PMS Activities
Top management should:

– Define, assign, and communicate responsibilities and authorities
– Ensure the availability of resources with independence
and competence
– Establish a PMS team that is cross-functional
Remember that everyone has a role to play in postmarket activities
– Assign responsibilities and determination of required competence
Summary: Best Practices for Postmarket Surveillance
Document a procedure to define postmarket surveillance activities

Set a review time frame based on risk classification of device and
device family
Document completed reviews, and then look back to the risk
management documentation:
– Document the evaluation, even if there are no changes or there is no
impact on the product
– Don’t forget to evaluate social media (Facebook, Twitter, Instagram, etc.),
as these are popular places for people to make comments and vent
If FDA requires postmarket surveillance in accordance with 21 CFR
822, complete and document the required activities
The EU has very extensive requirements for Postmarket Activities
– Annex III of the EU MDR defines technical documentation requirements
for postmarket
– Ensure that these requirements are met on an ongoing basis
Postmarket Surveillance Planning
It All Starts with a Plan
Planning Define postmarket surveillance system
Postmarket Establish a postmarket surveillance system
Surveillance
Define, assign, and communicate responsibilities and authorities
Ensure the availability of resources with independence and
competence
Establish cross-functional PMS teams
Establish a procedure for how to make and maintain a PMS plan
Describe how and where the data are collected
Monitor postmarket data actively, proactively, and systematically
Use as a method to implement preventive or corrective action
Define how the postmarket process interacts with other QMS processes
Results are evaluated and reported to top management

Postmarket Surveillance: Planning
PMS Plan: Establish complaint reporting and vigilance reporting
Implementing Establish procedure for vigilance activities
and
Conducting Reference vigilance procedures as part of PMS plan
Define methods for communicating with:
• Regulatory Authorities
• Customers
• Other parties (Notified Body, Authorized Representative)
Ensure procedure for corrective action links to processes for:
• Customer complaint handling and trending
• Serious incidents and reporting
• Recalls and market corrections
Purpose of Postmarket Surveillance Plan
The PMS plan:

– Serves as the de facto protocol for conducting postmarket
surveillance activities of devices
– Establishes activities to be conducted in postmarket surveillance
– Documents the methods for collecting and analyzing PMS data
– Establishes the alert or action levels
– Defines the hand-off of analytical data to other QMS processes
– Defines the who, what, when, and how for the postmarket
surveillance activities for each device / device family
PMS
Plan

PMS Plan Development
Quality system procedures for postmarket surveillance

should identify the need to compile a PMS plan
The PMS plan should be a document in the QMS and
under revision control
This document can be updated / revised over the device’s life
cycle, but those changes should be controlled
PMS plans should be developed through the use of cross-
functional teams
Document the contents of the PMS plan and report via
standardized templates in the document control system to
ensure consistency
PMS Plan Outputs
Outputs from the PMS activities should be assessed at

management reviews
The PMS plan should be maintained throughout the
life cycle of the device
Outputs from the PMS plan link to risk management,
clinical and performance evaluation, product
realization, improvement processes, notifications to
Regulatory Authorities, and monitoring and maintaining
product requirements

Postmarket Surveillance Plan: The Information to Gather
The postmarket surveillance plan must address

collection and use of information that will be analyzed and
used for updates to other parts of the system
Common data points include:
– Information about serious incidents, including from regulatory reporting
and field safety corrective actions
– Records referring to nonserious incidents and data on any undesirable
side effects
– Information and actions from trend reporting
– Relevant specialist or technical literature, databases,
and / or (patient) registers
– Information, including feedbacks and complaints, Plan
provided by users, distributors, and importers
– Publicly available information about similar
medical devices
Postmarket Surveillance Plan: Contents

The postmarket surveillance plan covers:
A proactive and systematic process to collect required information
and allow correct characterization for device performance
Comparisons made between a subject device and similar products
available on the market
Effective and appropriate methods and processes to assess
collected data, including analysis
Suitable indicators and threshold values used in continuous
reassessment of the benefit-risk analysis and risk management
Effective and appropriate methods and statistical tools to investigate
complaints and customer feedback
Analysis of market-related experience collected in the field
Methods and protocols to manage events subject to trend reporting
EU MDR Annex III, (1.1b)

Postmarket Surveillance Plan: Contents, Cont.
The postmarket surveillance plan covers, cont.:

Establishment of any statistically significant increase in the frequency
or severity of incidents and observation period
Methods and protocols to communicate effectively with Competent
Authorities, Notified Bodies, economic operators, and users
Reference to procedures fulfilling the manufacturer’s obligations to
postmarket surveillance planning, reporting, and trending
Systematic procedures to identify and initiate appropriate measures,
including corrective actions
Effective tools to trace and identify devices for which corrective
actions might be necessary
A PMCF plan, or a justification if a PMCF plan is not applicable
EU MDR Annex III, (1.1b)
Postmarket Surveillance Plan Template
Handout: Postmarket Surveillance Plan Template

DISCUSSION: SURVEILLANCE ACTIVITIES
How will companies demonstrate how they’re handling the

activities boldfaced below?
1. Actively and systematically describe:
a) What type of data would be gathered for PMS data
b) Where this information would be recorded and how it would
be recorded
c) Methods for analyzing PMS data
2. Draw the necessary conclusions and describe:

a) How to determine actions that would be taken
b) Reporting activities and how these would be conducted
c) What type of monitoring of corrective actions would occur
EXERCISE 4-1: ASSESS FOR PMS REQUIREMENTS

Section Debrief
Key points or
takeaways
for section
Impact on your
organization
and / or your
job role
Next steps

Section 5:
Postmarket Surveillance Planning,
Data Collection, Appraisal, and Analysis
Using ISO/TR 20416:2020
SECTION 5: POSTMARKET SURVEILLANCE PLANNING, DATA COLLECTION, APPRAISAL, AND ANALYSIS
Learning Objectives
Describe the ISO/TR 20416:2020 planning process for

Develop a PMS plan
Define sources of PMS data
Define methods of data collection and appraisal
Describe how to compile reports on data analysis
Describe the interface of PMS with other QMS processes
Define PMS plan updating / review requirements
Identify best practices for PMS plan construction

ISO/TR 20416:2020 Medical Devices –
Post-Market Surveillance for Manufacturers
ISO/TR 20416:2020 Medical Devices –

Post-Market Surveillance for Manufacturers
Provides guidance on the postmarket surveillance process, including

discussions of:
– A proactive and systematic process to collect and analyze data
– Information for the feedback processes
– How to meet applicable regulatory requirements to gain experience from the
post-production activities
Guidance is complementary to the requirements in
ISO 13485 and ISO 14971 for production and post-production activities
to conduct PMS
Guidance can also be used by importers, distributors, and reprocessors
that play a role in PMS activities
– “Organization” is used in the guidance, but applicability isn’t limited to
manufacturers – it applies to importer, distributors, and reprocessors as well

Postmarket Surveillance Plan:
Purpose
EU
EU MDR PMS Plan Requirements MDR
The PMS plan is:

PMS
Plan – A required, standalone document
– Maintained as a controlled document
– Part of PMS technical documentation (Annex III,
Section 1.1); related to PMS report
– Documented in standardized PMS plan and report
templates to ensure consistency
It is required to have a documented process for
reviewing and updating the PMS plan, especially in
consideration of new developments, changes to product,
and changes in technology
The Notified Body’s QMS assessment includes the PMS
plan and its related processes
EU MDR Annex II (6.1(c))

ISO/TR
20416:2020
PMS Plan Outputs
A PMS plan should be maintained throughout the life cycle

of the device
Outputs from the PMS activities should be assessed at

management reviews
Outputs from the PMS activities are inputs to risk

management, product realization, improvement
processes, notification to Regulatory Authorities, and
monitoring and maintaining of product requirements
DEFINE OBJECTIVES

PMS Plan:
Structure of the Plan
Postmarket Surveillance: PMS Plan
A PMS plan should:

– Define the scope of the PMS activities
– Set the objectives of the PMS activities
– Identify the roles and responsibilities in the PMS plan
– Identify the sources of PMS data
– Define the methods for how the PMS data will be collected
– Describe how the PMS data will be analyzed
– Document the reporting of the PMS data
– Define the review of and updates for the PMS plan
Let’s talk about the details for creating the PMS plan…
As mentioned previously, since the EU is the most prescriptive, we
will refer to it for requirements
5-10
© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0
Common Structure for a Postmarket Surveillance Plan

Suggested Scope of activities
PMS Plan
1.0 Device(s) under evaluation
Table of
Contents Types of users
2.0 Objectives
3.0 Roles and responsibilities
4.0 Data sources
5.0 Methods used for data collection
6.0 Methods used for data analysis
7.0 Data analysis report
8.0 Current benefit versus risk profile and / or state of the art
9.0 PMS plan review and update requirements
10.0 Reference documents
11.0 Change history log

PMS Plan:
Defining the Scope
ISO/TR
20416:2020
PMS Plan: Defining the Scope
Scope will depend on the type of medical device

Proper scoping helps to gather and collect appropriate
PMS data to support safety and performance of the device
Scope should include:

– Brief description of the device
– Types of users
ISO 20416 section 5.2

ISO/TR
20416:2020
PMS Plan: Defining the Scope
Brief description of the device – consider addressing:

– Product, product family, accessories, connected devices
– Models or versions of device
– Intended use of the device
– Patient population that uses the device
– Lifetime of the device
– Reference to the countries where the device is available
– Regulatory classification of the device
– If the device is single use or reusable
– Describe the product’s life-cycle stage and the maturity of the product’s
technology in relation to state of the art
Types of users
– Describe the users of the device
– Include a reference to their training

PMS Plan:
Setting the Objectives
ISO/TR
20416:2020
PMS Plan: Establishing the Objectives
Remember why PMS activities are conducted:

– Monitoring medical device safety and performance
– Meeting regulatory requirements
– Contributing to life-cycle management
The PMS plan identifies PMS data to be collected to
support the objectives of the PMS plan
Define the objectives of the PMS plan:
– In relation to the device’s life cycle
– Intended use
– Applicable regulatory requirements
– Specifications of the medical device
© 2020
2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 5-18
ISO/TR
20416:2020
PMS Plan: Establishing the Objectives, Cont.
PMS plan objectives can support safety and performance

of the device, including:
‒ Opportunities for improvement
‒ Usability of the device
‒ Labeling
‒ Customer feedback
DEFINE OBJECTIVES
©
© 2021
2020 Oriel
Oriel STAT
STAT A
A MATRIX.
MATRIX. All
All rights
rights reserved.
reserved || PSF-R0
PSF-R0 5-19
DISCUSSION: FORMULATE PMS OBJECTIVES
ISO/TR 20416:2020, Section 5.3 lists questions to help you formulate

PMS objectives
Which of these questions are already considered in your organization’s

PMS system? Which are not?
For each question not considered, what system improvements might

you make in response?

PMS Plan:
Roles and Responsibilities
PMS Plan Content: Roles and Responsibilities
Define in the PMS plan the resources and the

responsibilities for PMS activities
Create a roles and responsibilities matrix, or include a
narrative section to define the roles and responsibilities
– Include a list of individuals, by department, who are involved in
PMS activity
– Include a list or references specific to the postmarket surveillance
responsibilities (not an exhaustive list, examples only):
Complaint handling: Gather adverse event reporting, recall data
related to the device
Production: Gather manufacturing nonconformance data
Sales / marketing: Determine device usage in a clinical application
Statisticians: Determine the statistical methodologies to be used for
analyzing collected PMS data
Servicing: Gather service / maintenance and warranty data
PMS Plan Content: Roles and Responsibilities, Cont.
Create a roles and responsibilities matrix, or include a

narrative section to define the roles and responsibilities, cont.
– Define competence of individuals in each role
– Reference how qualification can be obtained
PMS Plan Content: Use of External Resources
External resources can be used in conducting the

PMS activities
– Resources should be approved as service providers
through the purchasing controls process
– Gather the CV (curriculum vitae) as part of the supplier
documentation
– Document the training of the external resources on
PMS procedures
– A written quality agreement that defines the roles and
responsibilities should be in place

PMS Plan: Roles and Responsibilities to Document
Roles and Responsibilities Matrix

PMS Role Responsibility Competence
Complaint handling Gather data: Complaint handling / advisory
• Adverse event reporting notice reporting
• Field safety corrective
actions
• Specific device in related
scientific publications
Servicing Gather data: Service data
• Service/maintenance of
devices
Production Gather data: Manufacturing methods and
• Nonconformances nonconformances
Sales and marketing Provide data: Knowledge of the clinical
• Device usage in a clinical application and usage in the
application field
Statisticians Determine statistical methods Statistical methods for analyzing
for analyzing collected data data
Source: ISO 20416 section 5.4

PMS Plan:
Sources of PMS Data
Define Collection Methods for Each Data Source
Postmarket planning describes how to source data

– Identify known and unknown sources of information
– Adjust during postmarket surveillance as new sources of
information become available
– Planning is key = where is information obtained?
External PMS Data Sources Internal PMS Data Sources
Recalls databases Nonconformance data databases
Adverse event reporting databases Complaints database
Peer-reviewed scientific literature Service report analysis / databases
Social media posts Market surveys or focus group
Patient registries feedback
Trend analysis reports
Recall databases
Postmarket clinical follow-up report

PMS Plan: Developing the Data Collection Methodology

Identify in the PMS plan:
– Sources of PMS data (based on type of device)
Should align to the PMS plan objectives
Data should be gathered from both proactive and reactive PMS data sources
Data collection methods:

– Should align to the PMS plan objectives
– Define the data collection method for collecting the PMS data from each
of the identified data sources
– Specify the methods of searching for information
– Ensure information collected in this timespan is proportionate to risk and
applicable to the medical device / its intended use, in relation to both the
device technology and state of the art.
Source: MEDDEV 2.7.1 rev. 4 Section 6.3, © 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0
5-29
Selection of Data Collection Methods
The organization should consider the following

characteristics:
– Analysis method
– Sample sizes
– Goal of the method
The data collection period:

– Should align with the PM plan objectives
– Information collected in this timespan should be applicable
to the medical device and its intended use
Ensure that the timespan is appropriate with the state of the art
Timespans can be specific to each data source and should
permit time for sufficient relevant data to be collected

Data Collection Methods
Data collection protocol should:

– Describe all steps to ensure consistency of the collected data
– Consider the advantages and disadvantages of the method chosen
Considerations to take into account when developing
the protocol:
– How data collection will be conducted and documented
– Who will be responsible for recording the PMS data
– How the data will be monitored and possibly updated
– Who will be responsible for ensuring the data integrity and quality
of the data
Data collection protocols can be included in other
documents, such as the PMCF plan
Best Practice
PMS Plan Content: Data Collection
Data Source Role

Data Collection Method Objective
Identified Responsible
Search identified clinical literature,
Peer-reviewed clinical
☐ publication websites, journals,
literature: subject device
sponsored studies
Search identified clinical literature
Peer-reviewed clinical
☐ and equivalent device sponsored
literature: similar device
studies
☐ Complaint, feedback Search internal databases
Company-sponsored postmarket
☐ PMCF report
clinical follow up-studies
Postmarket clinical Company-sponsored postmarket

☐
follow-up studies surveillance, patient registries

Some Best Practices for Data Collection
Double-check all data sets and contents of reports

– Don’t rely on a report to capture all information needed
Pay attention to time periods covered by reports

– Make sure all time periods match the time period covered by
the PMS plan
– Ensure that the planning process defines time periods
Be careful about duplication

– Sometimes data can be captured in more than one place
(e.g., a clinical literature study complaint, a complaints database)
DISCUSSION: DATA COLLECTION CHALLENGES
Which aspects of the data collection process are most

challenging for your organization?
What can be done to improve data collection sources

and collection processes?

EXERCISE 5-1: CLINICAL DATA IDENTIFICATION

AND COLLECTION SOURCES

EU MDR and IVDR Trend Reporting
EU MDR and IVDR Reporting: Significant Increase
In the postmarket surveillance plan the manufacturer

must:
– Specify how to manage these “significant increase” incidents
– Define the methodology used to determine any statistically
significant increase
Applies to frequency or severity of such incidents
Defined for the observation period of the increase
Crucial to define trend reporting evaluation
Note: Monitoring device safety characteristics is a

proactive approach to understand links
to trending Plan
EU MDR Annex III 1.1(a)(b); EU IVDR Annex III 1.1(a)(b)

EU MDR and IVDR Trend Reporting: Significant Increase
Manufacturers need to establish “significant increase”

– In comparison with the foreseeable frequency or for severity of such
incidents in respect of the device
– Applies to one type of device or category or group of devices
– Must be defined for either a specific time period or for how frequency
or severity changes over a defined time period
– Specify these requirements in technical documentation and product
information, reference Annex III
– Should be proportionate to the risk of the device and its classification
EU MDR Article 88(1); EU IVDR Article 83(1)

Interfaces to Other QMS Processes
EU MDR Postmarket Surveillance System: Data Use

The PMS plan should state how the PMS data analysis will be used to:
– Update benefit-risk determination and improve risk management
– Update design and manufacturing information, instructions for use,
and labeling
– Update clinical / performance evaluation
– Update summary of safety and clinical performance, as applicable
– Identify needs for preventive, corrective, or field safety corrective
action in the market
– Identify options to improve usability, performance, and safety
– Contribute to postmarket surveillance of other devices, when
relevant
– Detect and report trends of defined periods
– Report to Regulatory Authorities
– Update technical documentation when needed
EU MDR Article 83(3); EU IVDR Article 78(3)

EU MDR Postmarket Surveillance System:

Corrective and Preventive Action
If the PMS identifies a need for preventive or corrective

action (or both), the manufacturer must:
– Implement the appropriate measures
– Inform the Competent Authorities concerned
– Inform the organization’s Notified Body, as required
The manufacturer must also report any serious incidents
or field safety corrective actions
– Refer to reporting of serious incidents and field safety corrective
actions (Article 87) for where and how to report
– Establish a procedure and process for reporting
EU MDR Article 83(4); EU MDR Article 78(4)

Review and Update of the PMS Plan
PMS Plan: Review and Update
A postmarket surveillance procedure should include the

criteria for review and updating of the PMS plan
For the PMS plan:

– Include a description of how the PMS plan is to be updated
– The process should have a defined minimum review period
– Just because the PMS plan is reviewed at certain intervals
does not mean a change is needed at each interval
– Document the review, even if changes to the PMS plan were
not needed

Updating the PMS Plan
Clearly define the criteria for reviewing the PMS plan
Risk-based triggers for updates to PMS plan include:

– Changes in state of the art or technology
– New clinical investigations (sponsor related or not)
– Design changes (significant)
– PMS data identifying new hazards / changes in hazards
– New clinical concerns or new intended uses
Updating the PMS Plan, Cont.
Include a review / update section in the PMS plan

Clearly define the criteria for reviewing the PMS plan
When reviewing the PMS plan, consider if:
– The data sources that were identified are correct or if additional data
sources should be used
– The time frame for the PMS data is appropriate
– The PMS data outputs provide the necessary information for reporting to
Regulatory Authorities, design inputs, and risk management
– Review frequency is dependent on outcome of the PMS activity
– There is no increase in trending on a mature product, whether a longer
review period should be considered
– Adverse events and / or negative trends warrant an increased time frame
in the plan
Changes are needed to the PMS plan for the next review

PMS Plan Content: Review and Update Interval
Updating the PMS Plan

List In the PMS plan’s update section, list reasons to update the PMS plan
Define In the PMS plan’s procedure section, define an interval period for review of
the PMS plan
Justify Include a justification or rationale for the review period
The PMS Plan and the PMS Report
The PMS plan’s review interval may not be as frequent as that for the postmarket
surveillance report
However, updates to the PMS report should trigger an automatic review of the PMS
plan in case anything changes, including:
• Scope of the activities, such as PMS data sources, new models
• Device under evaluation, such as expanded indications for use or different
intended purpose
• Design changes
• Changes in search terms or search criteria based on new indications

Best Practices for PMS Plan Construction
Best Practices: PMS Plan Construction
Follow the steps in the PMS guidance document for

constructing the PMS plan
Consider aligning the PMS device family to the RM file
and the CEP
The PMS plan should include a change history section
Maintain all associated information from data sources
used in the PMS plan as refence documents in an
appendix to the PMS report
Include the training / competency of PMS team members
in an appendix to the PMS report

Two Common PMS Plan Pitfalls
Potential Pitfall How to Handle

Writing the PMS Keep to the plan!
report in the PMS Include only content that is related to planning of the
plan PMS activities
Include only the necessary information to define and
guide the evaluation activity
It may be challenging to write a PMS plan for existing
products with current information
Appraising data in Save this for the PMS report!
the PMS plan The plan should be documented before the
evaluation – so you shouldn’t have anything
to appraise
Evaluation should not be done yet

PMS Data Collection:
Clinical Literature Search Plan and Strategy
Key Point About Literature Search Process
The clinical literature search process must be:
Systematic Reproducible
Plan what you will do Document every step and decision:

Do what you said you would do • What were the search criteria?
Document what you did • How were keyword combinations
and structure defined?
Document any adjustments or
• What was the search plan?
changes to search criteria
• What results did you get?
Record the results
• Which results were kept
for evaluation?

The Clinical Literature Search Plan: Search Strategy
Describe the search strategy:

– Where will you find the clinical literature you need?
Databases, public sources, other information sources
– How will you search for the information?
Search terms, keywords, Boolean indicators
– Prepare to document:
Date of search: {include all dates performed}
Name of person(s) undertaking the literature search
Period covered by search: {YYYY–YYYY} unless otherwise stated
Literature sources used to identify data
Let’s examine these

elements on the
following slides …
The Clinical Literature Search Plan:

Search Strategy – How
Options
Search Keywords: Examples include the device name and the
terms disease type
Subject headings: Refer to the database’s controlled
vocabulary to identify the needed search terms
Other access points (e.g., language, format, study type)
• Fields vary by database
Boolean and wildcard operators: Using combinations of
AND, OR, NOT, IS, “*” (wildcard) to refine or expand a search
• Options vary by database; refer to the database’s search
screen to find out how


Search Strategy – Where
Databases: Make information “findable”
What’s in a Format varies by database: For example, full-text articles, abstracts
database? only, citations only
Scope / coverage varies: For example, some databases include only
peer-reviewed articles
How is it Some databases assign subject headings to documents that cover
organized? the same subject (indexing): For example, MeSH (Medical Subject
Headings)
These subject headings come from a controlled list of terms
Using subject headings can make it easier to find relevant citations /
articles
What are Keywords Language
potential Subject headings Document type
access
points? Date Categories (e.g., clinical studies,
Title systematic reviews)
Author Journal name
And more, varies by database

Search Strategy – Where, Cont.
Examples
Databases Free access: Examples include PubMed, Cochrane Library,
Google Scholar
Commercial publishers (paid access): May provide access to
resources not available in free databases, examples include:
• Embase (European biomedical database)
• Scopus (“[T]he largest abstract and citation database of
peer-reviewed literature: scientific journals, books and
conference proceedings”)
• Web of Science (20,000+ journals covered)
• Ovid databases
Find URLs for these

examples on the next slide


Search Strategy – Where, Cont.
These are examples of databases; there are many

more available
̶ PubMed/MEDLINE: https://www.ncbi.nlm.nih.gov/pubmed/
̶ Cochrane Library: https://www.cochranelibrary.com/
̶ Embase: https://www.elsevier.com/solutions/embase-biomedical-
research
̶ Scopus: https://www.scopus.com/home.uri
̶ Web of Science: https://clarivate.com/products/web-of-science/
̶ Ovid databases: https://www.ovid.com/search-
result.html?q=*&classification_s=Database

Search Strategy – Other Information
How do you know you have searched enough?

1. Determine the scope / coverage of the databases you plan to use
2. Then, assess the need to locate other information, such as
clinical trials:
Cochrane Central Register of Controlled Trials (CENTRAL)
Clinicaltrials.gov
WHO International Clinical Trials Registry Platform
“The Cochrane Collaboration recommends PubMed,

Embase and the Cochrane Central Register of Controlled
Trials (CENTRAL) at a minimum.”
Source: NIH Literature Search: Databases and Gray Literature
Find URLs for these

examples on the next slide


Search Strategy – Other Information, Cont.
Cochrane Central Register of Controlled Trials

(CENTRAL)
https://www.cochranelibrary.com/central/about-central
Clinicaltrials.gov https://clinicaltrials.gov/
WHO International Clinical Trials Registry Platform
https://www.who.int/ictrp/en/
NIH Literature Search: Databases and Gray Literature
https://www.nihlibrary.nih.gov/services/systematic-review-
service/literature-search-databases-and-gray-literature

Creating the Summary of Clinical Literature
Search Activities
Clinical Literature Search Summary: Findings
Summarize the literature search findings and put them in the

postmarket surveillance report (PMSR) or periodic safety
update report (PSUR)
Sample contents to add to the PMSR / PSUR:
Literature search methodology and selection criteria
• Scope
• Data selection process
• Methods for search strategy
• Selection criteria: inclusion and exclusion
• Database search details
• Supplemental search strategy information
• Document any adjustments made to strategy

Clinical Literature Search Summary: Findings, Cont.
Sample clinical literature search protocol reporting format

for inclusion in the PMSR / PSUR:
– Name of database:
Source: URL
Search date: {Enter all search dates when performed}
Date range: {YYYY DATE – YYYY DATE}
Search strategy
Search terms
Clinical Literature Search Summary: Findings, Cont.
Sample clinical literature search protocol reporting format

for inclusion in the PMSR / PSUR, cont.:
– Results of search
The results below are listed for the search terms of the respective number above
(TNTR = too numerous to review – review was performed with a shallow perspective):
1. 213690; TNTR
Total Initial Included
2. 5767; TNTR Keywords Number of Publications Duplicate Publications
3. 607 # Publications Reviewed for Review
4. 34 1
2
5. Etc. …
– Review
Narrative description of what was found

Clinical Literature Search Summary: Aggregate
Aggregate safety and performance data

– Show total number of adverse events in literature
– Create a table showing adverse events from each paper
– Give an adverse event rate for each paper, and overall in literature
– Discuss any serious events like deaths
Sample
table
format
Clinical Literature Search Summary: Conclusions
Prepare conclusions on safety and performance (obtained

from the clinical literature data)
– Does the device conform to GSPRs based on literature data?
– What key information has been identified for safety?
– What key information has been identified for performance?
– Do the risks outweigh the benefits as discussed in the data?
– Are all indications covered in the literature or are there gaps?
– Are there serious events or adverse events identified that were not
previously reported?

DISCUSSION: LITERATURE SEARCH
What literature data is currently included in your PMS

system, if any?
What would be relevant search terms / strings that you

would use for your product(s)?

Data Collection:
Databases
The Database Search Plan: Search Strategy
Describe the search strategy:

– Where will you find the PMS data you need?
Databases, public sources, other information sources
– How will you search for the information?
Device name, product code, regulation number, company name
– Prepare to document:
Date of search: {include all dates performed}
Name of person(s) undertaking the PMS database search
Period covered by search: {YYYY–YYYY} unless otherwise stated
PMS database sources used to identify data
‒ Document search results to be analyzed

External Databases:
US FDA TPLC Database
Total Product Life Cycle (TPLC) Database
FDA’s TPLC
PLC database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm

TPLC Database: Sample Results
TPLC Database: Sample Premarket Reviews

TPLC Database: Sample List of Substantially

Equivalent Products
TPLC Database: Sample Failures

TPLC Database and MAUDE
The failure link connects back to the MAUDE database
TPLC Database: Sample Recalls
This area of the database identifies any recalls during the

specified period
There is one for this product code:

TPLC Database: Sample Recalls, Cont.
More details about the recall:
DISCUSSION: FDA TPLC DATABASE
Discuss the value of the TPLC database for

complaint handling, CAPA, risk management,
and compliance
How does your organization view the usefulness of
this type of tool?
Do you use or are you aware of any similar tools?
What do you do for postmarket surveillance in
your organization?

External Databases:
Corrections and Removals
FDA Medical Device Recalls Database
FDA Medical Device Recalls database
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

MAUDE Database

Data Collection:
Patient Registries
Data Collection: Patient Registries
https://www.nih.gov/health-information/nih-clinical-research-trials-you/list-registries

PMS:
Conducting Data Appraisal and Data Analysis
Data Appraisal
Data appraisal of PMS data:

– Appraise each data set
– Evaluate quality of data
– Confirm scientific validity
– Confirm relevancy of data
– Weight data against criteria
– Generate appraisal plan
– Conduct the appraisal
MEDDEV 2.7.1 rev. 4 Section 9

MEDDEV
General Data Appraisal Process
Data appraisal
Do we have enough good data to support PMS objectives?
Data Data
Data appraisal
Go to analysis
Identify the information in each document

Evaluate the methodological quality of the work – the scientific validity of
the information
Determine the relevance of the information to the postmarket activities
Systematically weight the contribution of each data set
Source: MEDDEV 2.7.1 rev. 4 Section 9.1
Evaluating Methodological Quality and Scientific Validity
The evaluators should:

– Examine the methods used to generate / collect the data
and
– Evaluate how much of the effect is due to:

Device performance
Confounding influences
Bias
Random error
Inadequate disclosure of information
Misinterpretation
MEDDEV 2.7.1 rev. 4 Section 9.3.1

General Data Appraisal Process
Data appraisal questions to ask:
Is it scientifically valid?
What weight does the data
(confirm safety and
performance) point have compared to
other data?
Is it relevant based on
criteria established
in planning?
General Data Appraising Method
Data Appraisal
1. Create a data appraisal plan
2. Document the plan and appraisal in the PMS plan, PMSR
report, and PSUR report
3. Evaluate quality of data in a defined method
4. Conduct the data appraisal on all data sets
5. Determine relevance to the clinical data
6. Systematically weight the contribution of the data set
7. Document appraisal of data sets in the PMSR / PSUR
• Conduct a data appraisal for each data set, report, etc., as

relevant to the product family
• Document the results report
Data Appraisal Planning and Conduct
The Data Appraisal Plan
The Data Appraisal Plan: Typical Contents

Criteria for determining:
• Methodological quality and scientific validity of each data set
• Relevance to the clinical evaluation (intended purposes, claims)
Criteria for weighting the contribution of each data set to the overall
clinical evaluation
Should identify and attribute adequate weighting to both favorable
and unfavorable data (be thorough and objective)
For the criteria adopted for the appraisal:
• Should reflect intended clinical use of the device
• Should document and justify the criteria adopted for the appraisal on
the basis of current knowledge / the state of the art
MEDDEV 2.7.1 rev. 4 Section 9.2

The Data Appraisal Plan, Cont.
The Data Appraisal Plan: Typical Contents, Cont.

Can be qualitative or quantitative
• Qualitative appraisal may be adequate for established devices and
low-risk devices (not much data may be available)
Document the appraisal plan in the PMS report
Conducting the Data Appraisal
Conducting the Data Appraisal

The evaluators should:
Follow the appraisal plan and apply its criteria consistently
Base their appraisal on the full text of publications / documents
(not abstracts or summaries) to review:
• All of the contents
• The methodology used
• The reporting of results
• The validity of conclusions drawn from the investigation or report
Evaluate any limitations and potential sources of error in the data
Document in such a way that the appraisal

can be critically reviewed by others

WORKSHOP 5-2: DEVELOPING A POSTMARKET

SURVEILLANCE PLAN

PMS Data Analysis
PMS Plan: Data Analysis
Planning of data analysis:

– Document the method of data analysis in the PMS plan
– Methods of analysis vary and are dependent on the type of data to
be analyzed
– Identify and document methods to be used for data analysis prior
to the start of the data collection
– Action levels and alert limits should be established
– Quality of data is essential to the selection of the appropriate
method
– Choice of statistical methods depends on the data distribution
Describe the data appraisal method selected for the PMS

data in the postmarket surveillance plan

Data Analysis
The organization should consider the following

characteristics:
– Method used to analyze the PMS data (qualitative or quantitative)
– Sample size based on device usage
– Goal of the analysis method
Method of data analysis depends on the type of raw data
PMS Plan: Methods of Data Analysis
Methods for data analysis:

– Qualitative analysis:
Content analysis
Narrative analysis
– Examples include histograms and trend charts
– Quantitative analysis
Descriptive
Inferential statistics
Semi-quantitative includes both qualitative and quantitative analysis
– An example is statistical process control

Data Analysis: Qualitative Analysis

Qualitative analysis can:
– Support the following PMS objectives:
New risks
New techniques
New treatment methods
– Be used for PMS data sources:
Feedback
Literature searches
Standards / regulations
Customer communications
– Be used to initiate investigations:
Safety and performance, malfunctions, use errors
Single events or discontinuous data cannot use
qualitative analysis
Other Data Analysis Methods
Trend analysis
– Identify patterns over a specified timeframe
– Historical data can serve as baselines
– As an alternative action, alert limits can be set by management
or quality
– Continually collected data for a specific attribute over time
– Types of changes that a trend analysis can detect:
Significant trend
Sudden spike or outlier
Whether data is subject to cyclic effects
– Trending period should be long enough to see trends or cycle
effects over time (e.g., rolling 12 months)
– SPC-6 in a row typically depicts a trend

Data Analysis Methods, Cont.
Complaint rates
– Normalize the data
– Consider usage of device (single use or reusable)
– Examples: complaints per million; complaints per installed base
Bar charts
– Graphic presentation of frequency distribution
Pareto analysis
– Type of bar chart
– Ranks data by cause in order of decreasing occurrence
– 20% of causes generate 80% of problems
– Helps focus on issues to address
Graphic examples of some of these methods are
presented on the slides that follow
To © 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 5-109
Data Analysis Examples, Cont.
Trend chart example
Display Error/Error Code EO1

70
60
50
40
30
20
10
0
January February March April May June July August September October November December
Throughput time Operators Number

Bar chart example 1
Complaint Failure Reasons

100
90
80
70
60
50
40
30
20
10
0
Bar chart example 2

Normalized complaint data example

Normalized Complaint / MDR Rates
12.00%
10.00%
8.00%
6.00%
4.00%
2.00%
0.00%
1Q2015 2Q2015 3Q2015 4Q2015 1Q2016 2Q2016 3Q2016 4Q2016 1Q2017 2Q2017
Normalized Complaint Rate Normalized MDR Rate
Section Debrief
Key points or
takeaways
for section
Impact on your
organization
and / or your
job role
Next steps

Section 6:
Postmarket Surveillance Reporting and
Postmarket Clinical Follow-Up
SECTION 6: POSTMARKET SURVEILLANCE REPORTING AND POSTMARKET CLINICAL FOLLOW-UP
Learning Objectives
Discuss benefit-risk profile changes coming from PMCF

Discuss approaches to trend reporting identification,
collection, and monitoring
Identify similarities between EU regulatory requirements
for PMS reporting and ISO/TR 20416 guidance
Prepare a framework for PMS reporting

ISO/TR 20416:2020
Postmarket Surveillance Reporting
ISO/TR
20416:2020
PMS Report: ISO/TR 20416:2020, 5.7
Reports on data analysis should:

– Answer the questions identified in the plan
– Show evidence that data meet the objectives defined in the plan
– Summarize all results and conclusions after plan implementation
– Reference original data locations
– Document statistical decision-making criteria
– Provide recommendations based on the results
– Meet timing requirements for regulatory reporting
– Be controlled quality documents

EU MDR and IVDR
Postmarket Surveillance Reporting
EU Acronyms and Definitions to Know
PMS (postmarket surveillance): EU Medical Device Regulation

Article 2, 60
PMCF (postmarket clinical follow-up): EU Medical Device Regulation,
Annex XIV, Part B
PMS plan (postmarket surveillance plan): EU Medical Device
Regulation Article 84
PMSR (postmarket surveillance report): EU Medical Device
PSUR (periodic safety update report): EU Medical Device Regulation
Article 86
Vigilance reporting (postmarket surveillance): EU Medical Device

EU MDR and IVDR
PMSR and PSUR Reporting
PMSR / PSUR Report
Once the PMS plan has been executed, the PMS data
should be analyzed
Include in the PMSR / PSUR report:
– A “Brief Description of the Device” section – consider addressing:
Product, product family, accessories, connected devices
Models or versions of device
Intended use of the device
Patient population that uses the device
Life cycle of the device

EU MDR Postmarket Reporting: PMSR
PMSR
PMSR
Class I Devices
Class A, B IVDs Reporting
Reporting
Manufacturers must:
Prepare a postmarket surveillance report (PMSR)
– Summarize results and conclusions of analyses of PMS
– Include a rationale and description of any preventive and
corrective actions taken
Update the report when necessary
Internally, there should be a defined period for updating
Make the report available to the Competent Authority
upon request
EU MDR Article 85
Canada: Postmarket Summary Reporting

Summary of the requirements:
Medical device license holders:
What When
Analyze information received about the use of “Periodically” – factors include
the licensed Class II, III, or IV device(s) device’s risk profile, known issues,
summary report schedule
Prepare a summary report of the information Class II devices: every two years;
received during the reporting period covers information from prior
24 months
Class III and IV devices: every year;
covers information from previous
12 months
Notify Health Canada, if it is determined while Within 72 hours
preparing the summary report that there has
been a change in what is known about the
benefits and / or risks related to the device
Health Canada, Guidance on summary reports and issue-related analyses for medical devices, Part A (January 2021); Amended regulation effective December
23, 2021 (CMDR 61.4-61.6)
© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0b 6-10

Canada: Issue-Related Analyses of Safety and Effectiveness

Summary of the requirements:
Who Health Canada
What May request an analysis on a safety or effectiveness issue from manufacturer of a
Class I medical device, or the license holder of a Class II to IV medical device
When At any time (when postmarket information shows that the benefits and / or risks of
a device may have changed)
Manufacturer of a Class I device License holder of a Class II to IV device
Completes analysis and submits to Health Canada within requested time frame
Default time frame: 30 calendar days, but shorter time frame may be imposed
The analysis should contain the following sections:
Device complaints and incident reports Device malfunction trends, quality issues,
Clinical data and other evidence and results from other analyses
Exposure data or sales data Labeling
Conclusion
Health Canada, Guidance on summary reports and issue-related analyses for medical devices, Part B (January 2021); Amended regulation effective December
23, 2021 (CMDR 25.1 and 39)
© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0b 6-11
Postmarket Surveillance: Periodic Reports (PSURs)
PSURs are now required by the EU MDR and IVDR:

– Complete for each device and / or device family / group of
Class III, implantable, Class IIb, and Class IIa
– Complete for IVDs of Class C, Class D
– Link back to the postmarket surveillance plan
– Include in the technical documentation
– Need document identification number and revision level
Establish a procedure for generating, updating, maintaining,
and distributing PSURs to Regulatory Authorities

EU MDR and IVDR Postmarket Reporting:

PSUR for Higher Risk
Class IIa, Class IIb, and Class C, D

Class III Devices Reporting IVDs Reporting
Manufacturer prepares periodic safety update
report (PSUR)
– This applies to each device and, where relevant, for each
category or group of devices
The PSUR summarizes results and conclusions of analyses of
postmarket surveillance data
Include a rationale and description of any preventive and corrective
actions taken
Specific to Class III and implantable devices and Class C, D IVDs:
– PSUR uploaded into an electronic system for regulatory agencies to
review and assess – viewable by CAs and the Commission
– Electronic system managed by Notified Body
EU MDR Article 86

PSUR for Higher Risk, Cont.
PSUR Contents
Throughout the lifetime of the device, the PSUR must

set out the following:
– Conclusions of the benefit-risk determination
– Main findings of the PMCF, if applicable
– Volume of sales of the device
– Estimated evaluation of the size and other
characteristics of the population using the device
– Where practicable, the usage frequency of the device
There is no current defined format or structure for
PSUR reports—it may be defined by individual NBs
EU MDR Article 86


PSUR for Higher Risk – Updates
When to update the PSUR:

Class IIa When necessary* and at least every two years
Class IIb At least annually
Class III At least annually
* “When necessary” = Changes to the product risk

profile, significant serious incidents, or other actions
that pose a risk to the public
Note: The PSUR, except in the case of custom-made

devices, must be part of the technical documentation
EU MDR Article 86

PSUR for Higher Risk – Where
Where to store or submit the PSUR

Custom-made devices The PSUR is part of the documentation referenced
in Section 2 of Annex XIII Procedure for Custom-
Made Devices
Class III devices or Manufacturers must submit PSURs to the electronic
implantable devices system of the NB involved in the conformity
assessment
Class C and Class D The NB must review the report and add its
IVDs evaluation to the electronic system with details of
any action taken
– The PSURs and Notified Body evaluation shall
be made available to Competent Authorities
through the electronic system
Devices other than Manufacturers must make PSURs available to the
Class III devices or NB involved in the conformity assessment and,
implantable devices upon request, to Competent Authorities
EU MDR Article 86

PMSR / PSUR Report
Summary of the data analysis from each of PMS

data source
Recommendation if any actions are to be taken
Conclusion regarding risk / benefit ratio
Write the PMSR / PSUR report so that it tells the
story of the postmarket activity that was conducted
PMSR / PSUR Report, Cont.
Include in the PMSR / PSUR:

– If quantitative methods of data analysis were used, document the
decision-making criteria used, such as statistical significance or
confidence levels
– Summary of PMS data that demonstrates the objectives of the
PMS plan were met
– Appendices to the report
PMS raw data and all analysis
Training / competency records for those involved in the PMS activity
– Conclusion of the PMS activities
– Recommendations for further actions to be taken if warranted
(CAPA, risk management, etc.)

The level of detail in the postmarket report will depend on

the risk classification of the device and applicable
regulatory requirements
The PMS plan, PMS report, and all supporting data should
be controlled as quality system records and should be
under record retention as part of the maintenance of
technical documentation
The PMS plan will define the systematic review time for
the PMS data in the report
– Regulatory requirements may define intervals
– Risk-based triggers can affect the review period
Review time of PMS data should consider:

– Intended use of the device
– Learnings from prior PMS reports on device or similar devices
– Technology
– Proportionate to risk of the device

Postmarket Report and the CER
The postmarket surveillance report is an input to the CER

– The CER discusses the results of the PMS report
– The CER and PMS report cycles may not coincide, so the CER
may have extra PMS information (e.g., ad hoc info to add)
– The PMS report contents should be analyzed for impact on clinical
safety, clinical performance, and benefit-risk analysis
Technical
Technical
Postmarket Postmarket Postmarket Documentati
surveillance Documentati
surveillance surveillance onCER
activities on
plan report
Postmarket Report and the CER, Cont.
The CER writer should ensure there are no new

outstanding PMS issues (complaints, CAPAs, etc.) from
the previous PMS update
The company should set a policy for how close to the
CER timing the ad hoc PMS data should come
– Ad hoc PMS data right up until the CER release date?
– Until end of previous quarter or update?
– Align review periods between the CER and PMS
Date of last Current date: Date of next

PMS update Updating the CER PMS update

Evaluating State of the Art Across

Postmarket Activities
Alternate State of the Art Clinical claims

therapies
Safety
Performance outcomes
outcomes
Patient
populations
Consistency
Intended use
CER
Target
therapies
Residual risks
Technique
PMS data Indications
CER Relationship to PMS and State of the Art
Risks
Benefits
These documents are Claims in labels,

labeling, IFU
examples of how
SSCP (Class III and
benefit-risk of a device implantable only)
is addressed through Main question
PSUR / PMSR
postmarket surveillance from postmarket
Clinical
evaluation report data accumulation:
Do the benefits continue
Risk management file
to outweigh the risks?

DISCUSSION: BENEFIT-RISK PROFILE CHANGES
What actions should be taken if there is a change in the

benefit-risk profile as a result of information coming from
the PMCF?
Postmarket Updates: A Continuous Process
Using the data from postmarket surveillance activities,

you should:
– Evaluate whether updates are needed to the benefit-risk profile,
clinical safety, or clinical performance of the device
– Identify any gaps in clinical evidence
– Generate additional clinical data necessary to address
outstanding issues via PMCF
– Analyze all relevant clinical data to reach conclusions

EU MDR Vigilance Reporting

Serious Incidents and Field Safety
Except for investigational devices, manufacturers must report to the relevant Competent
Authorities any:
Serious incidents Except for expected side effects that are documented in
involving devices made product information, quantified in technical documentation,
available in the and subject to trend reporting
EU market If the incident occurs outside the EU, there is no
requirement to report it in the EU – even if the device is
marketed in the EU
Field safety corrective Includes any field safety corrective action undertaken in
actions for devices made countries outside Europe for devices legally made available
available in the EU market in the EU market
for which actions have Only if the reason for the field safety corrective action is
been taken not limited to the device made available in countries outside
the EU
Submit reports to the electronic system for vigilance and postmarket surveillance
Expect MEDDEV 2.12/1 to be updated in the future

EU MDR Article 87 to align with new EU MDR requirements

EU MDR and IVDR Serious Incidents and Field Safety

Corrective Actions
This investigation must include a risk assessment of the

incident and field safety corrective action
Consider these criteria, as appropriate:
– Causality
– Detectability
– Probability of recurrence of the problem
– Frequency of use of the device
– Probability of occurrence of direct or indirect harm
Severity of that harm
– Clinical benefit of the device
– Intended and potential users
– Population affected
EU MDR Article 89 (1 and 3)
EU MDR and IVDR Vigilance Reporting: Timelines
When to report:
Any serious incident Immediately after the manufacturer has established
the causal relationship* with its device or that such
causal relationship is reasonably possible, and
not later than 15 days after the manufacturer has
become aware of the serious incident
In the event of a serious public Immediately, and not later than 2 days, after the
health threat manufacturer becomes aware of this threat
In the event of death or Immediately after the manufacturer establishes or

an unanticipated as soon as it suspects a causal relationship* between
serious deterioration in the device and the serious incident, but not later
a person’s state of health than 10 days after the date on which the
manufacturer becomes aware of the serious incident
* “Causal relationship” = how the device may have contributed or

contribute in the future to an event against a patient’s health and safety
EU MDR Article 87


Periodic Summary Reports
The manufacturer may provide periodic summary reports instead of individual serious
incident reports
There can be similar For which the root cause has been identified
serious incidents that OR
occur with the same For which a field safety corrective action has
device / device type been taken
and: OR
Where the incidents are common and well documented
Conditions apply! The coordinating Competent Authority must have agreed

with the manufacturer
Vigilance reporting has specified format, content, and frequency of the periodic
summary reporting to the authorities

EU MDR and IVDR Trend Reporting
EU MDR and IVDR Trend Reporting: What and When
Manufacturers must use the electronic system to report:

– Any statistically significant increase in the frequency or severity of
incidents that are not serious
– Incidents that are expected with undesirable side effects that could
have a significant impact on the benefit-risk analysis
– Incidents that have led or may lead to unacceptable risks to the
health or safety of patients, users, or other persons, when risks
are weighed against the intended benefits of the device
– There is currently no defined timeline for trending; it depends on
the type and risk classification of the device
We’ll unpack this information in the slides that follow

EU MDR and IVDR Reporting:

Significant Increase
In the postmarket surveillance plan the manufacturer

must:
– Specify how to manage these “significant increase” incidents
– Define the methodology used to determine any statistically
significant increase
Applies to frequency or severity of such incidents
Defined for the observation period of the increase
Crucial to define trend reporting evaluation
Note: Monitoring device safety characteristics is a

Plan
proactive approach to understand links to trending
EU MDR Annex III 1.1(a)(b)
EU MDR and IVDR Trend Reporting:

Significant Increase, Cont.
Manufacturers need to establish “significant increase”

– In comparison with the foreseeable frequency or for severity of
such incidents in respect of the device
– Applies to one type of device or category or group of devices
– Must be defined for either a specific time period or for how
frequency or severity changes over a defined time period
– Specify these requirements in technical documentation and
product information, reference Annex III
– Proportionate to the risk of the device and its classification

Tips for Trend Reporting
Describe in the procedure how a significant increase,

trending markers, spikes, or other actions are determined
– Trending activities should use some statistical methodology
depending on the risk of the device
– Specify the methodology, including trigger points and actions to be
taken, such as continued review or preventive actions
– Use historical data to calculate thresholds
If there are no historical data (i.e., if the product is new), then
establish the “significant increase” amounts and how continued
reevaluation is done
When a new product is introduced, there will be an increase in volume
and therefore an increase in trending, but this should be evaluated
against such factors as sales volume or use of the device
Tips for Trend Reporting, Cont.
Trend analysis should use statistical methodology that can

anchor or normalize the data
Define in the postmarket procedure what is “a significant
increase,” trending markers, spikes, or how other actions
are determined
Statistical techniques should be a procedure in the QMS

DISCUSSION: EU MDR AND IVDR

TREND REPORTING
How can the information for trend reporting be:

Identified?
Collected?
Monitored?

Relationship of PMS to PMCF
Postmarket Clinical Folllow-Up (PMCF) Planning
PMCF is part of the postmarket surveillance system

Must base PMCF on a plan
– EU MDR Annex XIV (5) says this can be part of the PMS plan
– Can be separate attachment or continuous document
PMS plan Technical

documentation
PMCF
plan

EU
EU MDR PMCF Overview MDR
PMCF is a continuous process that updates the

manufacturer’s clinical evaluation
– Required for certain types of high-risk devices
Purpose of PMCF:
– Confirm safety and performance of a device throughout its
expected lifetime
– Ensure continued acceptability of identified risks and detect
emerging risks based on evidence
Manufacturers must proactively collect and evaluate
clinical data:
– Applies to any human use of CE-Marked devices
– Applies to any device placed on the market or put into service within its
intended purpose
EU MDR Annex XIV Part B
The PMCF Process
Do the gathered clinical data:

Confirm that the device continues to meet safety and
performance requirements?
Ensure that previously identified risks still maintain an
acceptable benefit to risk assessment?
Identify new risks that impact the benefit to risk assessment? PMCF
Input
processes report
Postmarket clinical follow-up
Patient registries Risk management process

Complaints Clinical evaluation process
Feedback Design and development
Customer surveys CAPA process
Usability QMS reporting
Patient monitoring PMS process
Vigilance reporting

EU MDR PMCF Linkage to PMS
PMCF may be a continuation of clinical investigation

Biggest difference is that the device is now CE Marked
Patient
registries
PMS
Vigilance
Complaints
reporting
PMCF
Patient
Feedback
monitoring
Customer
Usability
surveys
EU MDR Annex XIV
PMS and PMCF Relationship
Systematic process and methodology

Actively collect data
Postmarket surveillance Collect and analyze all postmarket data
Determine effect on benefit-risk
Determine if device still meets GSPRs
Systemic process and methodology

Postmarket
clinical follow-up Proactively collect data
Collect and analyze all postmarket
clinical data
Determine effect on benefit-risk
Clinical investigation and other clinical data
Clinical evidence

EU
EU MDR Overview of PMCF Activities MDR
Postmarket
surveillance plan: Perform Analyze Document results in
• PMCF required? PMCF PMCF results a PMCF evaluation
• Document PMCF and data report
method
Use the PMCF Implement needed

Add the PMCF evaluation evaluation report preventive and / or
report to: for the required corrective measures
• Clinical evaluation report clinical evaluation identified during the
• Technical documentation and risk PMCF
management
EU MDR Technical Documentation and EU

PMCF Content MDR
Postmarket Update and review

Clinical Follow-Up the following:
Risk management
PMCF study
Clinical evaluation
Similar devices
Technical
Technical PMCF plan
Registry studies Documentati
Technical
Documentati
on
Documentation PMCF report
Clinical investigations on
EU MDR
Annex II Design changes
Clinical literature
Corrective action
Insurance database
information PMSR / PSUR
Patient surveys
Physician data
EU MDR Annex XIV

EU MDR PMCF Reporting
EU
EU MDR PMCF Evaluation Report MDR
The PMCF evaluation report is part of postmarket

surveillance and the CER
– This is a separate report referenced by the PMS report / PSUR
– Can also be an attachment / inclusion in the PMS report / PSUR
Because it is not likely that these devices will need

Class I and
PMCF, the report for these device classes is basically a
Class IIa devices
justification statement of why a PMCF is not required
Class IIb devices These devices must go through a continuous PMCF

and above process, so they will have a PMCF evaluation report

REF: MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies April 2020

EU
EU MDR PMCF Evaluation Report, Cont. MDR
The manufacturer must analyze the findings of

PMCF
the PMCF and document the results in the
evaluation PMCF evaluation report:
report
The PMCF evaluation report becomes part of the
clinical evaluation report and technical documentation
for the device
Conclusions of the PMCF evaluation report shall be
taken into account against clinical evaluation
Understand relationship to risk management
If need for preventive and / or corrective measures
has been identified, the manufacturer must implement
them as required
EU MDR Annex XIV Part B (7-8)
PMCF Evaluation Report:

Structure
Structure of the PMCF evaluation report is determined by

its contents:
– For example, can reference entire clinical study reports
– Literature search report (if a literature search occurred)
– In general, list and describe or reference all PMCF data
– The report must conclude with a benefit-risk determination:
Does the device meet the GSPRs based on this clinical data?
Has the benefit-risk ratio changed, given this data?
Are further studies needed to meet GSPRs or determine the
benefit-risk ratio?

PMCF Impacts
Remember: Update the PMS plan based on PMCF outcomes

Class I Class IM,
Activity Class IIa Class IIb Class III
(non) IS, IR
Every two
PSUR / CER PMSR* PMSR* Annual Annual
years
* Update as needed, or ~5 years
Update the CER using the same risk-dependent cycle, which may
or may not sync with PMS; may include current PMCF status in the
CER updates:
̶ Current status of the PMCF, adverse events, etc.
Also update the CER whenever product has significant changes in
risk, design, or registration (e.g., MDD Î MDR)
Important Tip
Stay current with MDCG guidance documents!

Guidance – MDCG Endorsed Documents | Public Health
(europa.eu)

EXERCISE 6-1: IDENTIFY SIMILARITIES IN

PMS REPORTING
Section Debrief
Section 6: Postmarket Surveillance Reporting and Postmarket

Clinical Follow-Up
Key points or
takeaways
for section
Impact on your
organization
and / or your
job role
Next steps

Section 7:
Technical Documentation and PMS
Linkages to QMS Processes
SECTION 7: TECHNICAL DOCUMENTATION AND PMS LINKAGES TO QMS PROCESSES
Learning Objectives
Interpret technical documentation requirements for

PMS from:
– ISO 13485:2016 Clause 4.2.3
– MDSAP Audit Approach
– EU MDR, IVDR Annex III Part B
Describe the life cycle management process for
technical documentation
– Linkages to QMS processes
Discuss best practices for linking postmarket
surveillance reporting to clinical evaluation and risk
management processes
Define Technical Documentation
What is technical documentation?
Documented evidence, normally an output of the quality

management system (QMS), that demonstrates
compliance of a device to the regulatory requirements for
products and processes

Relationship of Technical Documentation in QMS
Design
History File
Design and Regulatory

Manufacture Submissions
510(k) Submission Technical File (index)
Device Medical
Master Device
Record File
510(k) Indications GSPR Clinical Declaration
Summary for Use Evaluation of Conformity
Technical documentation includes premarket, production, and postmarket information

ISO 13485:2016 Clause 4.3.2
Medical Device File
ISO
13485:2016
Postmarket Surveillance in ISO 13485:2016
What is postmarket surveillance?

– Defined as a systematic process to gain information about
devices placed on the market
– The intent is to use the information for feedback into the risk
management process
Feedback: Are we meeting customer requirements?

– Gather and monitor information relating to whether the
organization has met customer requirements
– Include post-production and any postmarket surveillance
required by applicable regulations
Source: ISO 13485:2016

ISO
13485:2016
Postmarket Surveillance in ISO 13485:2016, Cont.
Establish and maintain a medical device file

– For each device type or medical device family, establish and
maintain a file containing or identifying documents that define:
Description and intended use
Product specifications
Specifications / procedures for manufacturing to distribution
Measuring and monitoring procedures
Installation and servicing (if applicable)
ISO
13485:2016
Feedback and PMS in Management Review
Management Review Inputs
Process
Complaints and
Feedback Performance
Reports
Measures
PMS
Proactive Reactive
Process
PMS PMS
Effectiveness

MDSAP Postmarket Technical Documentation
MDSAP Chapter 3: Measurement, Analysis & Improvement
Postmarket surveillance is embedded in all processes
Device Marketing
Management 1 Authorization and Facility 2
Registration
Risk Management
7. Purchasing
Measurement,
ure Medical Device Adverse
Analysis and 3 Events and Advisory 4
Improvement Notice Reporting
Design
gn and Device Marketing
5
p
Development Authorization and Facility
7
Registration
Production
duc
and Service 6
Controls

MDSAP Audit Approach: Keep Documentation Current
Are there arrangements in place to maintain the currency

of the technical documentation for all devices?
For example:
– A procedure for reviewing the currency of relevant standards and
conducting gap analyses as required
– A requirement to assess design changes and the need for further
technical testing
– A plan for postmarket clinical trials, where necessary, or periodic
literature reviews
MDSAP Audit Approach: More PMS Questions to Answer
Were sound methods used during PMS planning to

generate the technical documentation?
Is the information present and coherent?
Are conclusions substantiated?
Is the documentation applicable to the device and

marketing authorization?

EU MDR and IVDR Annex III Part B
EU MDR Annex III: Technical Documentation on EU

MDR /
Postmarket Surveillance, Cont. IVDR
Postmarket Planning Update and

review the
Similar
devices
following:
Serious
incidents Risk management
Technical
Technical
Postmarket
Clinical evaluation
Non- Documentati
serious
Documentati
surveillance
on
or performance
technical
on
PSURs
incidents
documentation
evaluation (IVD)
PMCFs
Trending
Design changes
QMS reporting
Literature
Corrective action
Complaints PMSR / PSUR
Annex III

EU MDR Compiling Technical Documentation:

Annexes I-III
Annex II
Verification
and
validation
Design and Postmarket
manufacture planning
Labeling Postmarket
information surveillance
Device Technical Reporting

description documentation requirements
Matrix of PMS Requirements
ISO 13485 MDSAP

Description EU MDR
Clause Process / Tasks
3.1, 3.2, 3.16, Article 10, 11, 13,
General 8.1
6.10, 6.11 14; Annex IX
Article 5, 10, 13,
Feedback 8.2.1 3.1, 3.2, 3.5, 3.12, 14, 83, 88, 89;
Annex III, IX, X, IX
Article 5, 6, 7, 11,
Complaint handling 8.2.2 3.12, 4.1 13, 14, 16, 83, 87,
89, 92; Annex III
Article 5, 10, 13,
Reporting to Regulatory
8.2.3 3.14, 4.1, 4.2 14, 83, 88, 89, 90;
Authorities
Annex III, IX, X, IX

Life-Cycle Management of
Life-Cycle Management Strategies
Establish a procedure that reflects the product life cycle

Define trigger points for review
Address areas of life-cycle management in the procedure:
– Product and design changes
– Postmarket surveillance (customer complaints)—what to update
– Risk management monitoring
– Clinical evaluation updates and information (devices)
– Performance evaluation updates and information (IVDs)
Use the QMS change control system to monitor activities
Implement review periods for all components

Life-Cycle Strategies for Document Updates
Postmarket surveillance demands a proactive approach:

– Define a process for complaint handling as input to the
feedback system
– Reexamine hazards or risks of the medical device
– Link corrective action events to the PMS plan
– Update the PMS plan periodically
– Define when information is reviewed
Trigger points when customer awareness is needed
Specified time periods based on the PMS plan
A number of serious incidents for the same thing
One (significant) incident
Trending / trend analysis of a specific type of complaint
Life-Cycle Strategies for Document Updates, Cont.
Define review period for:

– Risk management files
– Clinical evaluation (device); performance evaluation (IVD)
Define activities that trigger a review of documents
– Serious incidents that may affect safety or performance
– Changes to intended purpose or patient population
– Issue that occurs in the field or with similar devices
Document any changes through the QMS change
management system and review the impacts
Identify reasons for the updates or changes

Setting the Stage for Life-Cycle Management
Trending of Customer Complaint seen before?

complaints complaint
received
Quality Determine Address in

metric as serious risk
review incident management?
Corrective Input into

action management
review Now part of
completion postmarket surveillance
Is reporting
Update clinical Final necessary? Reporting
evaluation report to to
report or authorities authorities
performance
evaluation Include in the PSUR
report (IVD) Review GSPR for Complaint (periodic safety update
impact on risk investigation
report)
Has the risk increased?
Integrating Risk Management Through the Life Cycle

Monitor continued use
of device and changes Is a new hazard observed
Customer or an increase in trend?
to design feedback
Multiple inputs into New hazards
risk management with the product?
Risk PMS
management activities
Information gained
Is the benefit-risk from customer use
analysis still valid? Clinical benefits Changes from
and new indications increasing hazards
or new hazards
Changes in the Clinical
clinical evidence evaluation or
Design Improvement in the
performance
changes design or function
evaluation
(IVD)
Each stage of life-cycle management can be followed through
other processes that are integrated and managed by the QMS
Life-Cycle Model from Regulatory Perspective:

Postmarket
Registration
CE Marking Postmarket
Eudamed
Economic Declaration of Vigilance
operators Conformity
PMS plan
UDI EC Certificate of
Conformity PMCF
Certificates and
reports Labeling Corrective actions
Ongoing processes
DISCUSSION: AUDITING THE DOCUMENTATION
How will the Notified Body auditors review PMS technical

documentation? What will they review?
What will they ask to see? Where would they start the
PMS technical documentation review?
What will they examine? What records will they examine?

Preparing for Notified Body Review of

Maintain technical documentation

9 Identify processes to review the documentation regularly
9 Update methods in place, including impact of changes
9 Ensure that changes are reviewed and a mechanism exists for
notifying Regulatory Agencies (Notified Body)
Ensure that current versions of documents are available
Create an index to help facilitate retrieval
9 Technical documentation information supports review by NB
9 National authority also assesses NB’s review process
9 Needs to be consistent among review processes
9 Incorporate into internal audit review of technical documentation
Postmarket Activities: Keeping Up to Date

Technical Declaration of conformity (DofC)
documentation General safety and performance requirements (GSPR)
Common specifications (CS) and standards
Postmarket Postmarket surveillance report (PMSR)
reporting Periodic safety update report (PSUR)
Vigilance activities
Clinical Clinical evaluation report (CER) or performance
evaluation evaluation report (PER)
Postmarket clinical follow-up report (PMCF report)
Performance
evaluation (IVD)
Product safety Summary of safety and clinical performance (SS&CP)

and performance Risk management file (RMF)

Linkages Between Postmarket Surveillance
Reporting, Clinical Evaluation, and Risk
The PMS Process
Does this device comply with the GSPRs?

Has the benefit-risk ratio changed?
Input PMS report
processes
Postmarket surveillance
Input and output

Risk management process to process Risk management process
Clinical evaluation process Clinical evaluation process
Complaint-handling process Design and development
CAPA process CAPA process
Clinical research / SOA QMS reporting
Design change and process changes PMSR / PSUR
Incidents / nonconformances
Vigilance activities

EU MDR Postmarket Linkages to ISO 13485
Summary of MDR Requirement
Postmarket surveillance (PMS) system

PMS system is part of technical documentation of product
Reporting of safety characteristics of devices on the market
Reporting in Eudamed system
Postmarket surveillance system: section 7.2, 7.2.3, 8.2.1, 8.2.2, 8.3.3

Reporting to agencies on vigilance: sections 7.2.3, 8.2.2, 8.2.3, 8.3.3, 8.5
Trend reporting of product: sections 8.1, 8.2.5, 8.2.6, 8.3, 8.4, 8.5
PMS System: Input into Clinical Evaluation
The postmarket surveillance plan addresses:

– The data that needs to be collected, per EU MDR Annex III (1.1a)
– The process for collecting, appraising, analyzing, and taking action
based on the data, including reassessing the benefit-risk analysis
and risk management
– Among other things, the plan includes the PMCF plan
Results of the postmarket surveillance activities serve as
an input into the CER
The results of postmarket data could drive:
– Changes to IFU
– Updates to risk management documents

Eudamed and Postmarket Surveillance
What Is Eudamed?
The European Database for Medical Devices (Eudamed

or EUDAMED) is a repository for information on
medical devices
– Currently, only Competent Authorities, Notified Bodies, and the EC
can access Eudamed
– The EU MDR and IVDR expand access to some information to:
Medical Device Coordination Groups (MDCGs)
Economic operators, such as manufacturers and
Authorized Representatives
Non-European market regulators
Public entities, such as medical institutions and press organizations
Limited information available publicly to all parties

Role of Eudamed as an Electronic System

Devices
Registration
Economic
Operators
Multiple database or
Issued, a single database?
Single Registration Number (SRN)

Expiration
Suspended,
for Economic Operators

Certificates
Withdrawn
Unique Device
Identification
Eudamed
SSCP Single interface that

points to multiple
Serious
Incidents databases?
Vigilance FSCA, FSN
Clinical Corrective
Investigations Actions What will be public
Market information and
Postmarket Surveillance what will not?
Surveillance
PSURs
Eudamed Features for Postmarket Surveillance
Additional features of the Eudamed database for PMS

activities include:
– Multiple reporting methods
Serious incident reports
Field safety corrective actions
Manufacturer registration and UDI
– Multilingual operations
– Web-based data exchange capabilities
– More access by different parties
– Defined methodology for keeping databases updated
– Sharing of information with other Regulatory Agencies
EU MDR Article 33

EXERCISE 7-1: ORGANIZE POSTMARKET

TECHNICAL DOCUMENTATION
Section Debrief
Key points or
takeaways
for section
Impact on your
organization
and / or your
job role
Next steps

Section 8:
Successful PMS Audit Outcomes
SECTION 8: SUCCESSFUL PMS AUDIT OUTCOMES
Learning Objectives
Review areas of focus from Notified Bodies

Review areas of focus on Notified Bodies
Describe an overview for auditing the postmarket
surveillance system
Prepare for PMS audits
Create an action plan

Areas of Focus From Notified Bodies
Notified Body auditors will look for:

1. How the process comes together
Consider a matrix of the reports and plans
Consider expressing the process as Plan-Do-Check-Act
2. How the process interrelates with others
This is why we focused on process mapping
Note inputs, activities, outputs, and feedback
3. Compliance
Remember, regulations are minimum requirements
Areas of Focus on Notified Bodies
Notified Bodies will themselves be assessed using PMS

data as a guidance (Art. 44)
MDCG may recommend that the sampling of PMS data by

Notified Bodies in an audit be increased or decreased
(Art. 45)
Recall: The additional of PMS is one of the most important changes

from the Directives to the Regulation
EU MDR Annex VII 4.5.2

Overview for Auditing PMS
Auditor must:
Create an audit program that demonstrates complete coverage of
the manufacturer’s PMS and to determine whether it meets
criteria in EU MDR, IVDR, and ISO/TR 20416, if applicable
Audit the PMS process to ensure it is controlled, has the
appropriate outputs (such as PSUR), and contains both proactive
and reactive inputs
Audit the processes that intersect with the PMS, including risk
management and QMS processes
Evaluate PMS evidence according to Annex II requirements and a
sampling plan
Ensure that audit findings are appropriately and consistently
classified
Preparing for PMS Audits
Enlist the internal audit team to help

Ensure job descriptions and training records are updated
Practice the process – even if you are a Class I
manufacturer, be disciplined in creating a PMS report
Take credit for the existing inputs from subprocesses like
complaints, feedback, marketing intelligence, etc.
Be able to explain the process – visually is best!
Be sure process owners are trained in how to be audited
– PMS documents may have been managed by the regulatory functions
who were not audited; if so, they will need additional training

Remember the Purpose
Monitoring medical device safety and performance

– Incorporating risk management
Meeting regulatory requirements
– Not just EU, also MDSAP
Contributing to life-cycle management
– Feedback into design
PMS is a super process:

consider it as important as product realization,
another super process in the QMS
EXERCISE 8-1: DEVELOP AN ACTION PLAN FOR A

SUCCESSFUL PMS OUTCOME
8-8
Thank You and Next Steps
Next Steps
Thank you for attending this class!
Next step: Apply what you learned as soon as possible to

“cement” your new knowledge and skills
Learn Apply Master
© 2021 Oriel STAT A MATRIX. All rights reserved. | AMF-R2 8-10

Next Steps: Professional Development
21st-century workers must be career-long learners

Recommended related courses include:
Topic Course
Risk management ISO 14971 Medical Device Risk Management
Training
Complaint handling Medical Device Complaint Handling, Event
Reporting, and Recall Management Training
Visit https://www.orielstat.com/courses/medical-device-RA-QA
Additional Support Options from Oriel STAT A MATRIX

Our experienced consultant team can help you with:
Baseline Audits – Understand your current compliance

level against EU MDR and IVDR requirements; develop a
roadmap to close gaps.
Closing Gaps – Implement the gap closure roadmap,

address deficiencies.
Preassessment Audits – Perform a final run-through before

the AO certification audit.
Contact Your Account Manager to Learn More

Questions?

Ebook PostmarketSurveillanceTraining (PSF-R0a V2)

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Ebook PostmarketSurveillanceTraining (PSF-R0a V2)

Uploaded by

Copyright:

Available Formats

Medical Device Postmarket Surveillance

(PMS) Program Implementation Training

OUR LIFE SCIENCES PRACTICE SUPPORTS MEDICAL DEVICE MANUFACTURERS

Global Regulatory Affairs

For more information, visit us at www.orielstat.com or call us at 1.800.472.6477.

SECTION 1: COURSE OVERVIEW

 Introduce Oriel STAT A MATRIX

 Introduce the course

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-2

Who Is Oriel STAT A MATRIX?

 91% of the largest device  Address all phases of the product

50 YEARS OF EXPERIENCE GLOBAL REACH

 Founded in 1968  Customers in 75+ countries

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-3

SECTION 1: COURSE OVERVIEW

1983  Oriel Inc. is founded (originally called Joiner Associates).

2001  STAT A MATRIX acquires Oriel, becomes Oriel STAT A MATRIX.

TODAY  Consulting – premarket, product realization, and postmarket

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-4

Full Life-Cycle Support

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-5

SECTION 1: COURSE OVERVIEW

Full Life-Cycle Support, Cont.

 Full spectrum support: Oriel STAT A MATRIX offers a complete

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-6

SECTION 1: COURSE OVERVIEW

Student Manual: Table of Contents

 Section 1 Course Overview

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-8

 The course agenda is your roadmap to the course

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-9

SECTION 1: COURSE OVERVIEW

1. Clearly define postmarket surveillance in your organization,

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-10

Course Objectives, Cont.

4. Create a postmarket surveillance plan based on related

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 1-11

SECTION 2: QUALITY MANAGEMENT SYSTEM REQUIREMENTS

 Clearly define postmarket surveillance in your organization

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 2-2

SECTION 2: QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Postmarket Surveillance: FDA vs. EU

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 2-4

Key Definitions for Postmarket Surveillance

EU Medical Proactive, systematic activities carried out by

ISO Systematic process to collect and analyze experience

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 2-5

SECTION 2: QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Postmarket Surveillance Defined

 A quality management system:

ISO 9000:2015, 2.2

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 2-6

Overview of Postmarket Surveillance Activities

 Postmarket surveillance should include:

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 2-7

SECTION 2: QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Potential Postmarket Surveillance Sources

 This list is not exhaustive, but it provides examples of

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 2-8

Who / What Requires Postmarket Surveillance?

 ISO 13485 – Clause 8.2 Monitoring and Measurement

© 2021 Oriel STAT A MATRIX. All rights reserved. | PSF-R0 2-9

SECTION 2: QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Introduce Oriel STAT A MATRIX

Introduce the course

91% of the largest device Address all phases of the product

Founded in 1968 Customers in 75+ countries

1983 Oriel Inc. is founded (originally called Joiner Associates).

2001 STAT A MATRIX acquires Oriel, becomes Oriel STAT A MATRIX.

TODAY Consulting – premarket, product realization, and postmarket

Full spectrum support: Oriel STAT A MATRIX offers a complete

Section 1 Course Overview

The course agenda is your roadmap to the course

Clearly define postmarket surveillance in your organization

A quality management system:

Postmarket surveillance should include:

This list is not exhaustive, but it provides examples of

ISO 13485 – Clause 8.2 Monitoring and Measurement

Japan MHLW Ordinance No. 169, updated by MHLW

All conformity assessment procedures (as well as medical

Organize a team that will manage postmarket activities

Ultimately, everyone in the organization is responsible

PMS is holistic and systematic; it is not the responsibility

The process approach includes designing the organization’s

Understanding and managing interrelated processes as

The process approach:

What are some examples of interrelated processes in

Reflect on your QMS

ISO 13485:2016 clauses related to postmarket surveillance:

In MDD, postmarket surveillance (PMS) was covered in a

For each device or product family, the manufacturer

In the EU MDR, a QMS is not required by EU MDR

Manufacturers must have a postmarket surveillance

Discuss compliance with the adverse event and

EU MEDDEV 2.12-1 Rev 8 – Guidelines on a medical

Health Canada Guidance Document for Mandatory Problem Reporting