PMCF Plan and PMCF Report under MDR 2017/745: What You Should Know

1. Introduction

The Medical Device Regulation (EU) 2017/745 (MDR) requires manufacturers to establish and maintain a Post-Market Clinical Follow-up (PMCF) system as a vital component of the Post-Market Surveillance (PMS) strategy.

The PMCF process consists of three critical elements:

• A PMCF Plan, which outlines the proactive methods and procedures to collect and assess post-market clinical data.

• PMCF Activities, which are the structured actions (general or specific) carried out according to the plan.

• A PMCF Evaluation Report, which documents, analyses, and interprets the results of the activities performed.

In this comprehensive blog post, you’ll learn how to properly structure and implement both the PMCF Plan and PMCF Report under the MDR, based on MDCG 2020-7 and MDCG 2020-8 guidance.

2. PMCF Plan – Structure and Purpose

2.1 Objective

The PMCF Plan serves as a proactive framework under the PMS system. Its purpose is to define the general and specific activities used to generate clinical evidence for CE-marked devices post-market. This ensures:

• Ongoing confirmation of safety and performance

• Identification of emerging risks or side effects

• Continuous reassessment of the benefit-risk ratio

• Monitoring for off-label or unintended use

• Updates to the Clinical Evaluation Report (CER), Risk Management File (RMF), and PMS documentation

This aligns with Annex XIV Part B of the MDR.

2.2 PMCF Plan Content and Format

Following the MDCG 2020-7 PMCF Plan Template, the required sections include:

Section A – Manufacturer Contact Information

• Legal entity name and address

• Single Registration Number (SRN)

• Regulatory compliance officer contact details

Section B – Medical Device Description

• Device name, model, classification, UDI-DI

• Intended use, user profile, and target population

• Device variants, accessories, and expected service life

Section C – PMCF Activities

• Detailed description of each activity (literature search, PMCF study, surveys, registries)

• Objectives, design justification, methodology, and sample size

• Limitations or foreseeable challenges

• Activity timelines (e.g., quarterly, annually)

⏰ Example: A 12-month retrospective registry study targeting real-world safety and usability data.

Section D – Technical Documentation Linkage

• References to CER and RMF sections where gaps or residual risks are identified

Section E – Use of Similar or Equivalent Devices

• Description of devices used as additional clinical data sources

• Relevance and justification of their inclusion

Section F – Standards and Guidance

• Harmonized standards, common specifications, and MDCG guidance applied

Section G – PMCF Report Timeline

• Estimated delivery date of the PMCF Evaluation Report (e.g., yearly or every two years)

3. General and Specific PMCF Activities: Definitions and Application

3.1 General PMCF Activities

These are broader, low-intensity methods suitable for lower-risk or mature devices. General activities include:

• Adverse Event Database Reviews

• Systematic Literature Reviews

• User Feedback Surveys

They help monitor trends, confirm existing evidence, and identify new clinical signals without involving complex data collection.

🔍 Note: General activities are effective when the device has well-established clinical performance and minimal residual risks.

3.2 Specific PMCF Activities

These methods focus on directly addressing gaps or uncertainties and are suitable for novel, implantable, or high-risk devices. Examples include:

• Clinical Investigations (PMCF Studies)

• Prospective or Retrospective Real-World Data Collection

• Validated Patient-Reported Outcome Measures (PROMs)

Each activity must:

• Be traceable to a defined clinical objective

• Be based on sound methodological principles

• Include justifications and expected impact on the benefit-risk profile

3.3 Summary Table of PMCF Activity Types

🧩 Tip: Combine general and specific PMCF activities in your plan to align with device risk and regulatory expectations.

4. PMCF Evaluation Report – Scope and Requirements

4.1 Purpose

The PMCF Evaluation Report documents the execution of PMCF activities. It includes:

• Summary and analysis of collected clinical data

• Interpretation of results

• Justification for technical file updates (or not)

This complies with MDCG 2020-8 and Annex XIV Part B.

4.2 Content and Structure

Section A – Manufacturer Contact Info

Carries over from the PMCF Plan.

Section B – Device Description

Refer to the Plan unless changes occurred post-market.

Section C – Description of Activities

• Overview of completed activities

• Collected data and methodology

• Deviations from the initial plan

• Analysis quality and limitations

Section D – Data from Similar/Equivalent Devices

• Summary of findings and relevance

• Evaluation of state-of-the-art comparison

Section E – Impact on Technical Documentation

• Whether CER, RMF, SSCP, or PMS plan require updates

Section F – Standards and Guidance

• Confirmation of applicable standards used during evaluation

Section G – Conclusions

• Summary of findings on safety, performance, and benefit-risk

• Recommendations for PMS and further PMCF planning

5. PMCF Study: Purpose, Design, and When It Is Required

A PMCF study is not automatically required for all devices but is necessary under certain conditions. As per MDR Annex III, a PMCF plan must always be included in the PMS plan.

When a PMCF Study Is Required:

• Reliance on equivalence without direct clinical data

• Novel technology or clinical application

• High-risk or implantable device classification

• Use in special patient populations

• Uncertainty from previous evaluations or literature

PMCF Study Design Types:

• Prospective Studies: Designed for planned future data collection

• Retrospective Studies: Analysis of existing real-world clinical data

• Registries: Longitudinal data collection for performance monitoring

• Surveys with PROs: Validated instruments for patient feedback

Each study requires:

• A clearly defined clinical objective

• Ethical oversight and regulatory alignment

• Detailed methodology and statistical plan

📄 Tip: Include the study synopsis or protocol as an appendix to the PMCF Plan and link it in the CER.

6. Common Pitfalls in PMCF Planning and Reporting

PMCF Plan Issues

• Vague objectives with no clinical specificity

• Poorly justified methods or sample size

• Missing activity timelines or endpoints

• Failure to justify absence of clinical investigations

PMCF Evaluation Report Issues

• Data presented without interpretation

• No conclusions or traceability to clinical objectives

• Activity results not linked to the CER or RMF

• Surveys lacking validation or proper design

Consequences:

• Delay in CE certification

• Rejection of clinical documentation

• Need for corrective submissions

⚠️ Ensure your PMCF documentation is proactive, traceable, and based on clear clinical objectives.

7. Key Elements for a Robust PMCF Approach

To comply with the MDR and expectations of notified bodies, your PMCF strategy should answer the following:

• What type of clinical data is the activity intended to generate?

• What are the clinical questions or residual risks it addresses?

• Does the method align with the device’s intended use and lifecycle?

• Are activity protocols referenced and available?

• Can the results support updates to the CER and benefit-risk analysis?

✅ A robust PMCF system is not only documented—it is justified, relevant, and strategically aligned.

8. FAQs About PMCF Plan and PMCF Report under MDR 2017/745

What is the purpose of a PMCF Plan under MDR?
To proactively gather post-market clinical data that supports ongoing safety and performance.

How often should the PMCF Evaluation Report be updated?
At least annually, depending on device class and risks.

Is a PMCF study required for Class I devices?
Not usually, unless there are emerging concerns or limited pre-market data.

Can user surveys replace clinical investigations?
Only for low-risk devices with no major performance uncertainties.

What happens if my PMCF documentation is inadequate?
Expect delays in certification and possible rejection of your technical file.

Can I use literature reviews as standalone PMCF?
Only if they are comprehensive and address all residual risks.

 9. Final Thoughts

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✌️ Peace,
Hatem Rabeh, MD, MSc Ing
Your Clinical Evaluation Expert & Partner