PMCF Under EU MDR: Writing the Plan and Evaluation Report Notified Bodies Accept

The clinical evaluation report is finished, the technical documentation is ready for submission, and then the notified body’s question arrives: your PMCF plan lists “literature review and complaint monitoring” but does not explain what clinical question those activities answer. Or the PMCF evaluation report summarises a year of activity without saying whether anything changed in the clinical evaluation or the risk file.

Both problems come from treating post-market clinical follow-up as a formality. Under the EU MDR, the PMCF plan is a specific document with minimum content set by law, and the PMCF evaluation report has to feed real conclusions back into your clinical evaluation. This guide explains what Annex XIV Part B requires, how the MDCG 2020-7 and MDCG 2020-8 templates structure it, and where submissions usually fall short.

What the MDR requires from a PMCF plan

Annex XIV Part B of Regulation (EU) 2017/745 defines PMCF as a continuous process that updates the clinical evaluation, addressed in the manufacturer’s post-market surveillance plan. Annex III Section 1.1(b) makes the link explicit: the post-market surveillance plan must contain a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.

Section 6.1 of Annex XIV sets the aims. The PMCF plan must specify the methods and procedures for proactively collecting and evaluating clinical data in order to:

• confirm safety and performance throughout the expected lifetime of the device;
• identify previously unknown side-effects and monitor identified side-effects and contraindications;
• identify and analyse emerging risks on the basis of factual evidence;
• ensure the continued acceptability of the benefit-risk ratio;
• identify possible systematic misuse or off-label use, with a view to verifying that the intended purpose is correct.

Section 6.2 then lists the minimum content of the plan:

1. general methods and procedures, such as gathering clinical experience, user feedback and screening of scientific literature;
2. specific methods and procedures, such as evaluation of suitable registers or PMCF studies;
3. a rationale for the appropriateness of those methods;
4. a reference to the relevant parts of the clinical evaluation report and to risk management;
5. the specific objectives to be addressed by the PMCF;
6. an evaluation of clinical data relating to equivalent or similar devices;
7. reference to relevant common specifications, harmonised standards and guidance on PMCF;
8. a detailed and adequately justified time schedule for PMCF activities, such as analysis of PMCF data and reporting.

Items (c), (e) and (h) are where most plans are thin. A list of activities without a rationale, objectives tied to specific open questions, and a justified schedule does not meet Section 6.2.

Using MDCG 2020-7 to structure the PMCF plan

MDCG 2020-7, the PMCF plan template published in April 2020, is not legally binding, but notified bodies know it well and a plan that follows its order is easier to assess. Its sections are:

• A — Manufacturer contact details: legal manufacturer, SRN, person responsible for regulatory compliance, authorised representative.
• B — Device description and specification: intended purpose, intended users and patient population, indications, contraindications, variants, accessories, classification, expected lifetime, and whether the product or procedure is novel.
• C — PMCF activities: one subsection per activity, each classified as a general or specific method, with its aim, the source that created the need (CER, risk management report, post-market surveillance), the rationale and the timeline.
• D — References to the technical documentation: the parts of the clinical evaluation report and risk management file to be monitored.
• E — Equivalent or similar devices: devices whose data will be evaluated, with their CER references.
• F — Standards and guidance applied.
• G — Estimated date of the PMCF evaluation report.

The most useful discipline in the template is Section C’s requirement to state where each activity comes from. If your clinical evaluation report under EU MDR concludes that long-term data on a sub-population are limited, or the risk management file lists a residual risk whose frequency is estimated rather than measured, the PMCF plan should contain an activity designed to answer exactly that question, with an endpoint and a reason why the chosen method can answer it.

MDCG 2020-7 also notes that PMCF data on continuing safety and performance should come from the device under evaluation. Data from equivalent or similar devices (Section E) are context, not a substitute. This matters for manufacturers who built their clinical evaluation on demonstrating equivalence: the PMCF plan is where you start generating data on your own device.

Writing the PMCF evaluation report with MDCG 2020-8

Annex XIV Part B Section 7 requires the manufacturer to analyse the PMCF findings and document the results in a PMCF evaluation report, which is part of the clinical evaluation report and the technical documentation. Section 8 requires the conclusions to be taken into account in the clinical evaluation and in risk management, and any preventive or corrective measures identified to be implemented.

MDCG 2020-8, published alongside the plan template in April 2020, mirrors the plan’s structure so that each planned activity has a matching result:

• Sections A and B: manufacturer and device details, including Basic UDI-DI, certificate, CND code, class and classification rule.
• Section C — Results of PMCF activities: results of each activity, data quality, justification for any deviation from the plan, and impact on other documents.
• Section D — Equivalent or similar devices: results and analysis of the relevant clinical data.
• Section E — Impact on the technical documentation: effect on the clinical evaluation report and risk management file, with dates and versions.
• Section F — Standards and guidance applied.
• Section G — Conclusions: findings against the aims of the PMCF plan, preventive or corrective measures, and input to the next PMCF plan.

Section E matters most: a report concluding “no new risks identified” without the version of the updated CER or risk file does not show that the loop was closed.

How PMCF connects to Article 61, the PSUR and the SSCP

Article 61(11) MDR requires the clinical evaluation and its documentation to be updated throughout the device’s life cycle with clinical data from the PMCF plan and the post-market surveillance plan referred to in Article 84. For class III and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance under Article 32 must be updated at least annually with such data.

Article 86 adds a second destination. The periodic safety update report (PSUR) for class IIa, IIb and III devices must include the main findings of the PMCF. Class IIb and III PSURs are updated at least annually; class IIa PSURs when necessary and at least every two years. For class III and implantable devices the PSUR goes to the notified body through the electronic system referred to in Article 92. Align PMCF reporting dates with the PSUR cycle so the PSUR quotes a finished analysis. MDCG 2022-21 (December 2022) gives the Commission-endorsed PSUR guidance.

The PMCF plan and report both sit within the technical documentation under Annexes II and III, so version control across CER, risk file, PMCF report and PSUR is part of the same exercise.

When PMCF is not performed: the justification

Annex III allows a justification instead of a PMCF plan, and MDCG 2020-7 confirms that the notified body assesses any justification for not performing PMCF. A credible justification explains, by reference to the clinical evaluation and the risk management file, why the existing clinical data are sufficient across the device’s expected lifetime and why post-market surveillance data will detect emerging risks without proactive clinical data collection. A sentence saying the device is “well established” is not enough, and the justification must be revisited whenever the clinical evaluation is updated.

Where this goes wrong

• Activities with no clinical question. The plan lists literature screening and complaint review but never states which residual risk, performance claim or evidence gap each activity addresses. Section 6.2(c) and (e) require a rationale and specific objectives.
• A generic time schedule. “Ongoing” or “annually” without a justification does not meet Section 6.2(h). State when data will be analysed and reported, and why that interval suits the device’s risk and expected lifetime.
• Relying on equivalent-device data indefinitely. Equivalence may support initial certification; the PMCF plan is expected to generate data on your own device.
• No feedback loop. The PMCF evaluation report ends with a conclusion, but the CER and risk management file carry the same version numbers as last year. Section 8 of Annex XIV Part B requires the conclusions to be taken into account.
• PSUR and PMCF out of step. The PSUR is written before the PMCF analysis is complete, so its “main findings of the PMCF” are a placeholder.
• Survey designs that cannot answer the question. A user satisfaction questionnaire will not confirm a complication rate. If the objective is a clinical endpoint, the method must be capable of measuring it.
• Mismatched device scope. Variants, accessories or the device class in the PMCF plan differ from the CER and the certificate.

Frequently asked questions

Is a PMCF plan mandatory for every device under the MDR?

Annex III Section 1.1(b) requires the post-market surveillance plan to contain either a PMCF plan under Annex XIV Part B or a justification as to why PMCF is not applicable. So every manufacturer must address PMCF; what varies is whether a plan or a documented justification is appropriate. For devices that need a notified body, that justification is assessed as part of the review.

How often must the PMCF evaluation report be updated?

For class III and implantable devices, Article 61(11) MDR requires the PMCF evaluation report to be updated at least annually. For other classes the MDR sets no fixed interval; the schedule follows the justified timeline in your PMCF plan under Annex XIV Section 6.2(h), and the report should be timed so that its main findings can feed the PSUR under Article 86.

Are MDCG 2020-7 and MDCG 2020-8 legally binding?

No. Both templates, published in April 2020, state that they are not European Commission documents and that their views are not legally binding. The legal requirements are in Annex XIV Part B of the MDR. However, notified bodies and competent authorities use the templates as a reference, so following their structure makes your plan and report easier to assess.

What is the difference between general and specific PMCF methods?

Annex XIV Section 6.2 distinguishes general methods, such as gathering clinical experience, user feedback and literature screening, from specific methods, such as evaluation of registers or PMCF studies. General methods apply to most devices. Specific methods are needed when the clinical evaluation leaves questions, such as long-term outcomes or residual risk rates, that general methods cannot answer.

Can data from an equivalent device replace PMCF on my own device?

Annex XIV Section 6.2(f) requires an evaluation of clinical data on equivalent or similar devices, so such data belong in the plan. MDCG 2020-7, however, notes that PMCF data on continuing safety and performance should come from the device under evaluation. Equivalent-device data provide context and comparison; they do not replace data from your own device.

If you need a PMCF plan and evaluation report built around your clinical evaluation, or a gap review before your next notified body audit, Medfins has supported 175+ regulatory projects across 250+ products. See our CE marking and EU MDR support or contact our team.