Maintaining your QMS

under EU MDR & IVDR

MARCH 15, 2021
WEBINAR
 MEDICAL DEVICE QUALITY IS ALL WE DO,
AND WE’RE ALWAYS AHEAD OF THE GAME.

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 Rook Quality Systems is a consulting firm dedicated to
helping startup to mid-sized medical device companies
develop and maintain effective and efficient quality
systems.
Rook Quality We provide specialized and custom consulting services
for all classes of medical devices, including medical
Systems software and combination devices.

Quality System DHF/ TF Audit Support Software

Design Creation Validation

Design Control Risk Regulatory Quality System

Management Submission Training
Support (Int’l)
 KYLE ROSE, PRESIDENT
Medical Device expert specializing in development of efficient Quality Systems for small
and startup medical device companies
Works as a contract Quality Manager for multiple medical device companies overseeing
overall quality strategy and ensuring compliance through documentation and auditing
Intro to services
Certified quality auditor (CQA) and has regulatory and submission experience for a
Kyle Rose variety of markets including FDA, CE Mark, Health Canada, and CFDA
Serves as a quality mentor to many medical device incubators around the world
Rook Quality encourages the simplification of Quality Systems to reduce the quality
burden and improve compliance through training and efficient QS design

Greenlight Guru Verification and Validation Design Control

Post Market Surveillance & Medical Device Software

PMCF Validation

Complaint Handling Quality System Development Risk Management

ISO 13485:2016, 21 CFR 820, MDD Corrective and

and MDR, ISO 14971 Preventative Actions

Product Development Internal and Supplier Audits

Overview of Sections
Documentation and
requirements for each
Updates to Complaint Updates to comply with
category of Economic
Handling and Vigilance SPRs
Operators within the
supply chain

Incorporating UDI and

Procedures for the
EUDAMED into your New requirements for
regulatory compliance
labeling and traceability Implantable devices
strategy
SOPs
Overview of QMS from MDR
The quality management system shall address at least the following aspects:
a) a strategy for regulatory compliance, including compliance with conformity assessment
procedures and procedures for management of modifications to the devices covered by the
system;
b) identification of applicable general safety and performance requirements and exploration
of options to address those requirements;
c) responsibility of the management;
d) resource management, including selection and control of suppliers and sub-contractors;
e) risk management as set out in in Section 3 of Annex I;
f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
Overview of QMS from MDR
The quality management system shall address at least the following aspects:
g) product realization, including planning, design, development, production and service
provision;
h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant
devices and ensuring consistency and validity of information provided in accordance with
Article 29;
i) setting-up, implementation and maintenance of a post-market surveillance system, in
accordance with Article 83;
j) handling communication with competent authorities, notified bodies, other economic
operators, customers and/or other stakeholders;
k) processes for reporting of serious incidents and field safety corrective actions in the
context of vigilance;
l) management of corrective and preventive actions and verification of their effectiveness;
m) processes for monitoring and measurement of output, data analysis and product
improvement.
Overview of QMS from IVDR
The quality management system shall address at least the following aspects:
a) There are specific features of in vitro diagnostic medical devices, in particular in terms of risk
classification, conformity assessment procedures and clinical evidence, and of the in vitro
diagnostic medical device sector which require the adoption of specific legislation, distinct from
the legislation on other medical devices, whereas the horizontal aspects common to both sectors
should be aligned.
b) The requirement to reduce risks as far as possible should be fulfilled taking into account the
generally acknowledged state of the art in the field of medicine
c) To ensure that devices manufactured in series production continue to be in conformity with the
requirements of this Regulation and that experience from the use of the devices they
manufacture is taken into account for the production process, all manufacturers should have a
quality management system and a post-market surveillance system in place which should be
proportionate to the risk class and the type of the device in question. In addition, in order to
minimize risks or prevent incidents related to devices, manufacturers should establish a system
for risk management and a system for reporting incidents and field safety corrective actions.
Risk Management/Clinical from IVDR
The risk management system shall address at least the following aspects:
a) The risk management system should be carefully aligned with and reflected in the performance
evaluation process for the device, including the clinical risks to be addressed as part of
performance studies, performance evaluation and post-market performance follow-up. The risk
management and performance evaluation processes should be inter-dependent and should be
regularly updated.
b) It should be ensured that supervision and control of the manufacture of devices, as well as post-
market surveillance and vigilance activities concerning them, are carried out within the
manufacturer's organization by a person responsible for regulatory compliance who fulfils
minimum conditions of qualification.
c) It is necessary to ensure that the clinical evidence of devices is updated throughout their
lifecycle. Such updating entails the planned monitoring of scientific developments and changes in
medical practice by the manufacturer. Relevant new information should then trigger a
reassessment of the clinical evidence of the device thus ensuring safety and performance
through a continuous process of performance evaluation.
Post-Market Surveillance SOP
PMS Plan and Report update!
Consistent updates to Risk, CER and TF from PMS feedback
PMS Report for Class I devices

RMF

Manufactured
Device Design CER PMS
Design

TF
Post-Market Surveillance IVDR
a) Relevant data and information gathered through post-market surveillance, as well as lessons
learned from any implemented preventive and/or corrective actions, should be used to
update any relevant part of technical documentation, such as those relating to risk
assessment and performance evaluation, and should also serve the purposes of
transparency.
b) For each device manufacturers shall plan, establish, document, implement, maintain and
update a post-market surveillance system in a manner that is proportionate to the risk class
and appropriate for the type of device. That system shall be an integral part of the
manufacturer's quality management system
c) The post-market surveillance system shall be suited to actively and systematically gathering,
recording and analyzing relevant data on the quality, performance and safety of a device
throughout its entire lifetime, and to drawing the necessary conclusions and to determining,
implementing and monitoring any preventive and corrective actions
Post-Market Surveillance IVDR
Data gathered by the manufacturer's post-market surveillance system shall in particular be
used:
(a) to update the benefit-risk determination and to improve the risk management as referred
to in Chapter I of Annex I;
(b) to update the design and manufacturing information, the instructions for use and the
labelling;
(c) to update the performance evaluation;
(d) to update the summary of safety and performance referred to in Article 29;
(e) for the identification of needs for preventive, corrective or field safety corrective action;
(f) for the identification of options to improve the usability, performance and safety of the
device;
(g) when relevant, to contribute to the post-market surveillance of other devices; and
(h) to detect and report trends in accordance with Article 83.
Summary of Safety and Performance
IVDR
a) For class C and D devices, other than devices for performance studies, the manufacturer
shall draw up a summary of safety and performance.
b) The summary of safety and performance shall be written in a way that is clear to the
intended user and, if relevant, to the patient and shall be made available to the public via
Eudamed.
c) Contents of Summary:
a) a description of the device, including a reference to previous generation(s) or variants if such exist,
and a description of the differences, as well as, where relevant, a description of any accessories,
other devices and products, which are intended to be used in combination with the device;
b) the summary of the performance evaluation as referred to in Annex XIII, and relevant information
on the PMPF;
c) information on any residual risks and any undesirable effects, warnings and precautions.
d) Additional requirements per Article 29 IVDR
Article 86 Periodic Safety Update Report
Who? Class IIa, IIb, III devices
Procedures and templates/forms for completing
Periodic Safety Update Report (PSUR) Conclusions of
Risk-Benefit
Determination
Main Findings
Must be updated annually (IIa every 2 years) of PMCF

Class III and implants must submit PSUR to

Sales Volumes
EUDAMED and Usage
Frequency

New SOP!
Compliance!
Articles 87-89 Incidents and FSCAs
Ensure SOP outlines new requirements for reporting Incidents and FSCAs
◦ Detailing timeline requirements for Incidents and FSCAs
◦ SOP outlines statistical analysis of incidents and when to report to EUDAMED
◦ SOP incorporates risk into the investigation of the Incident/FSCA

Templates or Forms for the reporting of serious incidents

SOP
update!
Article 25 Supply Chain

New requirements for SOP must outline the Economic operators,

the documentation, process of device manufacturers, ARs must
approval, & identification and register within the
maintenance of supply traceability throughout electronic system
chain members the supply chain

New SOP!
Articles 27, 28 UDI and Labeling
New procedures should define UDI requirements for each device in accordance
with MDR
◦ SOP should define storage of the UDI at each level, electronically is preferred
◦ SOP should detail the process for importing UDI information into EUDAMED

An up-to-date list of all UDIs should be maintained

New SOP!
 New SOP!
Regulatory Compliance
Consultants

Roles and Responsibilities

to ensure Regulatory Management
Compliance

Strategy for Regulatory Qualifications

Compliance

PMS and Vigilance

Qualifications
Responsibility
Document Storage/Retention
What’s new?
◦ Show QMS is effective through the extended storage requirement
◦ Ensure records are available in the event of company bankruptcy or failure

10-15 years after

last device placed
on market
SOP
update!
Annex 1 Making Essential more General
The updated General Safety and Performance Requirements
(SPRs) should be included in the QMS and replace any
references to the previous Essential Requirements SOP
New checklists or forms should be used to document the update!
SPRs within the QMS and for each product

How is risk New

How are How are
of SPRs Quality
SPRs ID’d? SPRs met?
assessed? Process
 Risk
Management
Plan (per
Updates Device)

to SPRs Training on
Device Safety as
Analyze all risks
(including
Foreseeable
from ERs needed
Misuse)

Risk focused
Risk
Risk-Benefit
analysis for
each Hazard Risk Controls
and Overall
Residual Risk
Post-market
Risk
Management
(impact on
Probability/
Severity)
Additional Notes
Use of Common Specifications/Harmonized Standards as they are published
Annex IX
◦ Additional requirements for devices using Human or Animal Tissue
◦ Additional requirements for devices using Medicinal Substances

Update your Declaration of Conformity to MDR

IVDR Updates
◦ SOPs for companion diagnostics used with system
◦ SOPs and processes in place for product conformity verification Annex XI
◦ SOPs and processes in place for type-examination Annex X
 www.RookQS.com
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