Building a quality PMCF report per EU MDR

Abstract
The EU has introduced new Regulation (EU) MDR 2017/745 providing new requirements for Post Market
Clinical Follow up (PMCF). In this white paper we will discuss the requirements for preparing a PMCF
plan and report according to Regulation (EU) 2017/745, MEDDEV 2.12/2 REV 2 MEDDEV 2.12/1 REV 8
and MEDDEV 2.7/1 REV 4. The evaluators have focused on strengthening the PMCF process by instructing
the manufacturer to update the PMCF data as required. This change has taken place because of the
adverse events takes place in the past. We believe that this paper provides you an effective and accurate
PMCF guide for your products.

Contact us:
Ankit Shukla, Business Development Manager
ankit.shukla@saracasolutions.com
M: +1-993-591-2604
Table of Contents

1. Background ................................................................................................................................... 4
2. Introduction to Post Market Clinical Follow Up (PMCF).................................................................. 4
3. Objectives of PMCF studies ........................................................................................................... 4
4. When to Conduct a PMCF Study? .................................................................................................. 4
5. Requirements of PMCF plan .......................................................................................................... 5
6. Stages of PMCF studies .................................................................................................................. 5
7. Clinical Inputs for PMCF ................................................................................................................. 6
8. Evaluation of Current Clinical Experience & Emerging Risk ............................................................. 6
9. Options for PMCF Activities ........................................................................................................... 6
10. Conduct a PMCF Survey ................................................................................................................. 7
11. Requirements of PMCF report ....................................................................................................... 8
12. Role of NBs in PMCF ...................................................................................................................... 8
13. Challenges of PMCF Studies ........................................................................................................... 8
14. Timing of PMCF ............................................................................................................................. 9
15. Design of PMCF studies ................................................................................................................. 9
16. Sample structure of typical PMCF plan ........................................................................................ 10
17. Conclusion................................................................................................................................... 11
18. References .................................................................................................................................. 11
19. About the Authors ....................................................................................................................... 12
20. About SARACA ............................................................................................................................. 12

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 Acronym/Abbreviation Description

CER Clinical Evaluation Report

CS Common specifications

ER Essential Requirement

EU European Union

GHTF Global Harmonization Task Force

IFU Instructions For Use

MDR Medical Device Regulation

PMS Post Market Surveillance

CoI Conflict of Interest

PMCF Post Market Clinical Follow-Up

PSUR Periodic Safety Update Report

ISS Investigator-Sponsored Studies

SSCP Summary of Safety and Clinical Performance

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1. Background
In last few years, the medical device industry has gone through several changes for both manufacturers
and distributers to increase the safety and performance of devices and reduce the risk for end users.
The requirements of Post Market Clinical Follow Up (PMCF) has also gone through many changes, and
its proper implementation has become more important to ensure the safety and performance
throughout the lifecycle of the device. Among all these changes, a major change done by the EU in the
new regulation (Regulation (EU) 2017/745) is a separate part in an annexure (Annex XIV, part B) in
which all potential requirements related to PMCF have been listed. The EU has decided to implement
these changes to strengthen the requirements for claiming the safety and performance of the device
by the manufacturer. The PMCF process specifies the methods and procedures used to proactively
collect and evaluate clinical data in relation to the product’s safety as well as clinical performance.
In this white paper we will discuss the basic requirements for preparing an effective PMCF plan and
PMCF evaluation report.

2. Introduction to Post Market Clinical Follow Up (PMCF)

According to EU recent regulation MDR 2017/745, Post Market Clinical Follow Up (PMCF) shall be
understood to be a continuous process. The PMCF findings shall be addressed in the manufacturer’s
post-market surveillance plan and the clinical evaluation report (CER) should be updated accordingly.
The obligation of notified bodies to check the appropriateness of the PMCF plan (including for class III
and implantable devices for which a pre-CE clinical investigation is not planned).
When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the
use in or on humans of a device which bears the CE marking and is placed on the market or put into
service within its intended purpose. This reference is to in the relevant conformity assessment
procedure; with the aim of confirming the safety and performance throughout the expected lifetime
of the device; of ensuring the continued acceptability of identified risks; and of detecting emerging
risks on the basis of factual evidence.

3. Objectives of PMCF studies

A PMCF study should have a clear objective, address the identified residual risks, and be devised to
answer one or more specific questions that relates to clinical safety or clinical performance of the
device. A formal hypothesis should be clearly expressed. The PMCF plan shall specify the methods
and procedures for proactively collecting and evaluating clinical data with the aim of:
• Confirming the safety and performance of the device throughout its expected lifetime
• Identifying previously unknown side-effects and monitoring the identified side-effects and
contraindications
• Identifying and analyzing emergent risks on the basis of factual evidence
• Ensuring the continued acceptability of the benefit-risk ratio
• Identifying possible systematic misuse or off-label use of the device, with a view to verifying
that the intended purpose is correct.

4. When to Conduct a PMCF Study?

• Confirm the safety and/or clinical performance for a new indication
• Significant changes have been made to the medical device or labeling
• Risk classification of the device has increased

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 • Post-market surveillance activities have raised questions about safety, clinical performance,
or effectiveness
• On request from your notified body or regulatory authority

5. Requirements of PMCF plan

The PMCF plan should include at least:
• Gathering of clinical experience gained, feedback from users, screening of scientific literature
and of other sources of clinical data
• Evaluation of suitable registers or PMCF studies
• Relevant parts of the clinical evaluation report and risk management documentation
• Objective(s) of the PMCF as made clear within the PMCF plan
• Clinical data related to equivalent or similar devices
• Reference to any relevant common specifications, harmonized standards and guidance on
PMCF
• Time schedule for PMCF activities

6. Stages of PMCF studies

There are mainly four stages to perform PMCF, these are as follow:

Determine PMCF Create PMCF Develop PMCF PMCF evaluation

strategy plan objectives report

▪ Gap analysis for ▪ Post Market ▪ Proactive Clinical ▪ Gather clinical

PMCF data Surveillance Literature Review evidence on the
▪ Evaluation of ▪ Clinical Evaluation ▪ Customer Surveys device
current clinical Report ▪ Inputs from
▪ Enhanced
evidences ▪ Benefit-Risk Ratio clinical, post
Complaint and
conclusion Adverse Event market, risk,
Monitoring others?

▪ Company
Sponsored Clinical
Studies, Registries,
ISS

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7. Clinical Inputs for PMCF

Publicly available Clinical Main findings on current

Data Clinical Evaluation

Scientific literature of
Summary of Safety and
manufacturer and equivalent
Performance
device

Clinically relevant vigilance

Benefit vs. Risk analysis
information

Relevant PMS information and

Available feedback
CER findings

8. Evaluation of Current Clinical Experience & Emerging Risk

Marketing
Clinical experience Risk assessment
information
• Complaint trends • Sales data • New and
• Adverse events • Changes in emerging risks
• Recalls/FSCAs countries/regions • Hazard analysis
of distribution • Benefit-risk
assessment

9. Options for PMCF Activities

• Clinical literature
• Review any published scientific literature or study that references manufacturer products
• On equivalent or well-established competitor devices
• Use for clinical background and state-of-the-art
• Database /registries
• Review of relevant data from patients or users
• Use to compare the performance of user as per outcomes and resource
• Hospital
• Feedback

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 • Customer surveys
• Expert user groups (focus groups)
• User feedback
• Clinical study
• Randomized controlled trials
• Observational studies with controls retrospective,
• Case-control studies, cohort studies with controls

Comparison of Time, Cost & Effectiveness for the above PMCF Activities:
PMCF Activity Cost Time Effectiveness

Clinical Literature
Review

Surveys

Database/Registry
Review

Clinical Study

10. Conduct a PMCF Survey

• Parameters and endpoint cannot deviate from IFU and claims.
• Sample size is larger and center selection much wider to include multiple investigators.
• Primary purpose is verification of safety and clinical performance claims in larger, less
controlled group (“Real Life Data”).
• Use questionnaires that provide reliable and usable data.
• Use a validated tool to simplify GCP ISO 14155 and GDPR compliance.
• Select a tool that provides multiple ways to initiate surveys.

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 Design change

Corrective IFU/ labelling

action

PMCF Data

CER Public health

notification

Manufacturing
process

11. Requirements of PMCF report

The PMCF report should include at least:

• PMCF investigational plans

• Patient informed consent forms
• Device Instructions for Use and CE certificate
• Study site, qualification documents such as doctors’ CV
• Higher risk devices (implants, Class III) will require more clinical data; equivalence requires
agreement with manufacturer for access to tech data

12. Role of NBs in PMCF

• Audit manufacturer's general post-market surveillance procedures and plans, including plans for
PMCF
• May impose restrictions to the intended purpose of a device to certain groups of patients.
• Verifies that PMCF is conducted on behalf of the manufacturer as part of the overall clinical
evaluation.
• Shall check that the PMCF plan is appropriate and includes post market studies.

13. Challenges of PMCF Studies

• Device marketed is new and not much data is available from PMS Studies.
• Device PMS possess unique set of challenges related to diversity and complexity of these medical
devices in terms of nature of product development, technology behind it, and relatively short
product life cycle.
• Patients participating in study might not meet eligibility criteria and not in a position sometimes to
give informed consent.
• Lack of clear objectives, endpoints and research questions including identifying residual risks
hampers PMCF studies.
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14. Timing of PMCF
• PMCF shall be performed pursuant to documented method laid down in PMCF plan, specifying
general methods and procedures, such as gathering of clinical experience gained, feedback from
users, screening of scientific literature and other sources of clinical data.
• For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the
summary of safety and clinical performance referred to in Article 32 of MDR shall be updated at
least annually.

PMCF evaluation report Annex XIV part

Category/Report
B

Class-I When necessary

When necessary or at least every 2-5

Class-IIa
years

Class-IIb At least annually

Class-III At least annually

15. Design of PMCF studies

A PMCF study should be designed in such a way that its objective can be addressed clearly. Designs
may change depending on the objective, study hypothesis research questions and endpoints and
should be technically sound so that we can reach to the appropriate conclusions.
Manufacturers undertaking PMCF studies should prepare all required documentation for submission
to regulators for approval. These requirements include PMCF investigational plans; patient informed
consent forms; device Instructions for Use and CE certificate; and usually study site qualification
documents such as doctors’ CV. Increasingly, a statement confirming the absence of a Conflict of
Interest is demanded by the reviewing institutions. If there is a potential CoI (Conflict of Interest), then
the intended investigator should detail what that is or could be and justify their participation.

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16. Sample structure of typical PMCF plan
Section 1. Purpose

Section 2. Scope

Section 2.0.1 Product name

Section 2.0.2 Product catalog

Section 2.0.3 Product Description

Section 2.0.4 Legal Manufacturer

Section 2.0.5 Device class

Section 2.0.6 Intended patient population and Medical conditions

Section 2.0.7 Indication For Use

Section 2.0.8 Contraindications and warnings

Section 3. References

Section 4. Plan type / Plan lifecycle

Section 5. PMCF method and activities

Section 5.1 General method and ongoing activities for PMCF data collection

Section 5.1.1 Post Market Surveillance (PMS)

Section 5.1.2 Clinical Evaluation Report (CER)

Section 5.1.3 Benefit Risk Ratio Conclusion

Section 5.2 PMCF activities for data collection and data sources

Section 5.2.1 Proactive Clinical Literature Review

Section 5.2.2 Customer survey

Section 5.2.3 Enhanced Complaint and Adverse Event Monitoring

Section 5.2.4 Focus Group

Section 5.2.5 Marketing User Feedback Studies

Section 5.2.6 Company Sponsored Clinical Studies

Section 5.2.7 Company Sponsored Registries

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 Section 5.2.8 Company-Supported Investigator-Sponsored
Studies (ISS)
Section 5.3 PMCF Activity objectives

Section 5.3.1 Customer survey

Section 5.3.1.1 Survey objectives

Section 5.3.1.2 Survey distribution

Section 5.3.1.3 Survey collection period

Section 5.3.1.4 Sample size consideration

Section 5.3.1.5 Survey reporting

Section 5.3.1.6 Determine survey method

Section 5.3.1.7 Survey result

Section 6 Potential complaints

Section 7 Attachments

Section 8 Revision history

17. Conclusion
A prerequisite for the proper planning, budgeting, and execution of PMCF activities according to PMCF
planning is to create a comprehensive PMCF evaluation report. Hence suitable post market
surveillance systems programmed from a manufacturer’s quality point of view are needed for
identification and investigation of risks associated with use of medical device placed on the market.
Moreover, not only effective post market surveillance systems are needed from manufacturer’s side,
but also a well-defined strategy associated with post market surveillance has to be in place for each
medical device range. PMCF plays an exact role in defining undefined objectives and strategies by
means of clinical studies and registries. It is left on manufacturers to decide use of PMCF with a specific
criteria and purpose. Need for PMCF arises when medical devices are assessed through their
equivalent nature and in cases of devices where identification of possible emerging risks and long-term
safety evaluation and performance remains critical.

18. References
• Post market clinical follow-up studies, a guide for manufacturers and notified bodies
o https://ec.europa.eu/docsroom/documents/10334/attachments/1/translations
• Post-market Clinical Follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies
o https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_7_guidance_pmcf_
plan_template_en.pdf

• Official Journal of the European Union, (2017, May 5). MDR 2017/745, Retrieved from
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 o http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN
• European Commission. MEDDEV 2.7/1 revision 4 (June 2016). Clinical Evaluation: A Guide for
Manufacturers and Notified Bodies Under Directives 93/42/EEC.
• Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System
o https://ec.europa.eu/docsroom/documents/32305/attachments/1/translations

19. About the Authors

Arunansu Dash
A medical device professional with extensive experience in global medical device regulations. Arun
holds a bachelor’s degree in mechanical engineering. He has experience in regulatory, quality
assurance and manufacturing of intravenous (IV) medical devices, vascular access/central venous
access devices, plastic tubing, electro-mechanical medical systems, medical software, orthopedic
implants, and instruments. He has done risk assessment and analysis and authored multiple clinical
evaluation reviews spanning medical software, electronics products, patient monitoring devices,
orthopedics, surgical instruments, and laser phototherapy technologies.
He has authored clinical evaluation reports, technical files, and other regulatory documents for
submission in countries complying with EU regulations and U.S. FDA 510(k) with a strong background
in 93/42/EEC, Medical Device Regulation (EU MDR) 2017/745, MEDDEV 2.7/1, Rev 04, 21 CFR Part 820,
ISO 14971, IEC 62304, and ISO 13485. He also has a deep understanding of the State-of-Art (SOA) for
the relevant medical devices in the aforementioned market segments.

Kuldeep Tyagi
Kuldeep has in excess of 20 years of experience in the Medical Devices industry in design, development,
quality, regulatory/manufacturing of orthopaedic implants/instruments, electro-mechanical systems,
remote monitoring systems, radiology, cardiology, pathology and electro-therapy products. Kuldeep
critically appraises scientific literature, writes summaries for articles and surgical procedures, and
coordinates the efforts of cross-functional teams to produce scientifically accurate, high-quality
technical documents.
Kuldeep has worked in functional areas, including Product Design, Quality, Regulatory, Digital
Publications, Remediation, Additive Manufacturing, Supplier Selection and Consolidation. He has
global medical quality and regulatory experience, including US FDA, EU MDR, ISO 13485, ISO 62304,
and ISO 14971. He has experience working on research methodology and information management
with databases such as Medline, PubMed and Embase.
Kuldeep is an expert in the European medical device regulations and worked extensively on 93/42/EEC,
EU MDR 2017/745 and MEDDEV 2.7/1 Rev 4. He has authored Tech Files, CERs, and reviewed design
dossiers and regulatory documentation for class I, IIa, IIb and III medical devices.

20. About SARACA

SARACA is a medical engineering services company which specializes in providing innovative and cost-
effective deliverables with a core focus on customer satisfaction. Our business has a global reach and is
wholly focused on the medical products and devices market segment. We possess significant expertise in
the areas of: Spine, Trauma, ENT, Ophthalmic, Remote Monitoring Systems, IOT Gateways, Embedded

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Electronics, Emergency Care and Single Use Devices.

We are highly proficient at working within regulated environments such as those imposed by the US FDA
and the EU (ISO13485, CER, 21 CFR Part 820 Quality Management systems along with ISO14971 and
IEC62304). Our skills include developing Design Dossiers (DHF/Tech Files), 510(k) applications, UDI
implementation, Remediation of the Class I, II and III products, and CAPA Management.

Our capabilities include collaborating with our customers in collecting marketing requirements, global
product registration, quality engineering, installing/remediating QMSs, concept design, product
development, sustaining engineering, supplier selection/auditing, prototype development, contract
manufacturing and product testing.

___________________________ CONTACT US: ______________________________

Saraca Solutions Private Limited

Contact@saracasolutions.com
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