The PMCF Plan and Evaluation Report Under MDR Annex XIV Part B: Eight Contents and Five Objectives

Post-market clinical follow-up is the part of MDR 2017/745 that most often exists on paper and not in practice. A plan is written at certification, it names literature screening and complaint review as its methods, it sets no schedule that anyone tracks, and two years later there is no evaluation report because there were no findings to evaluate. Annex XIV Part B is short enough that this is avoidable; it is also specific enough that the deficiency is easy for a notified body to demonstrate.

This guide sets out what PMCF is defined to be, the five objectives the plan has to serve, the eight items it has to contain, what the evaluation report does with the results, and where the EU authorised representative encounters both documents.

The definition does the work

Section 5 of Annex XIV Part B defines PMCF in one sentence that decides several arguments. "PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer's post-market surveillance plan. 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 as referred 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." (MDR Annex XIV, Part B, Section 5)

Four words in that sentence carry most of the weight.

Continuous. PMCF is not an activity that happens when a report is due. It is a process that runs, and the report is a periodic account of it.

Updates. PMCF is not a parallel exercise to clinical evaluation; it is the mechanism by which the clinical evaluation stays current. A clinical evaluation report that has not moved since certification is evidence that PMCF is not functioning, regardless of what the PMCF plan says.

Proactively. This is the distinction between PMCF and the rest of post-market surveillance. Complaints, vigilance reports and returns arrive on their own; collecting them is reactive and belongs to the post-market surveillance system under Article 83. PMCF is what the manufacturer does to generate clinical data that would not otherwise arrive. A PMCF plan whose only methods are complaint analysis and vigilance review has described the PMS system and called it PMCF.

Within its intended purpose. The clinical data collected is data from use within the intended purpose covered by the conformity assessment. Data about off-label use is still relevant — objective (e) below makes that explicit — but it is relevant as a signal that the intended purpose may be wrong, not as evidence supporting it.

Section 5 also places PMCF inside the post-market surveillance plan. The two documents are linked by design: Annex III requires the PMS plan to address PMCF, and Section 5 requires PMCF to be addressed in it. Our note on the periodic safety update report covers the third document in this set.

The plan is mandatory in form

Section 6 is one line and it is a formal requirement. "PMCF shall be performed pursuant to a documented method laid down in a PMCF plan." (MDR Annex XIV, Part B, Section 6)

PMCF activity without a plan does not satisfy Annex XIV, even if the activity is substantial and the data is good. The plan is the document that lets a reviewer judge whether the methods are appropriate to the device before looking at what they produced.

Five objectives

Section 6.1 states what the plan's methods have to be aimed at. "The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of: (a) confirming the safety and performance of the device throughout its expected lifetime, (b) identifying previously unknown side-effects and monitoring the identified side-effects and contraindications, (c) identifying and analysing emergent risks on the basis of factual evidence, (d) ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and (e) identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct." (MDR Annex XIV, Part B, Section 6.1)

Objective (a) is tied to the expected lifetime, which means the PMCF horizon is set by the device, not by the certificate cycle. For an implant with a fifteen-year expected lifetime, a PMCF programme that stops at three years has not confirmed performance throughout that lifetime.

Objective (b) has two halves that need different methods. Identifying previously unknown side-effects requires something that can surface the unexpected — a registry, a prospective study, structured user feedback. Monitoring identified side-effects and contraindications is a tracking exercise against a known list. A plan that only does the second has answered half the objective.

Objective (c) contains a phrase that recurs across the Regulation: on the basis of factual evidence. Emergent risks have to be identified from data, not from a periodic brainstorm in a risk management review.

Objective (d) points at Sections 1 and 9 of Annex I and closes the loop with the risk management file. The benefit-risk ratio determined before market entry has to remain acceptable, and PMCF is the evidence stream that shows it does.

Objective (e) is the one most often omitted entirely. The plan has to include methods capable of detecting systematic misuse or off-label use, and the stated purpose of doing so is verifying that the intended purpose is correct. This is not a compliance-policing objective aimed at users. It asks whether the manufacturer's own definition of intended purpose matches how the device is actually being used in practice, and it can conclude that the intended purpose should change.

Eight mandatory contents

Section 6.2 sets out what the plan must include as a minimum. "The PMCF plan shall include at least: (a) the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data; (b) the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies; (c) a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b); (d) a reference to the relevant parts of the clinical evaluation report referred to in Section 4 and to the risk management referred to in Section 3 of Annex I; (e) the specific objectives to be addressed by the PMCF; (f) an evaluation of the clinical data relating to equivalent or similar devices; (g) reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMCF; and (h) a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer." (MDR Annex XIV, Part B, Section 6.2)

The split between (a) and (b) is the structural point of the whole section. General methods are the passive sweep — clinical experience, user feedback, literature. Specific methods are the active instruments, and the Regulation names two by way of example: evaluation of suitable registers, and PMCF studies. A plan that lists only general methods has filled in (a) and left (b) empty, which is the single most common PMCF deficiency and the one a notified body identifies fastest, because it is visible from the structure of the document.

Point (c) is what makes (a) and (b) defensible. The plan has to explain why these methods, for this device, are capable of answering the objectives in Section 6.1. A method list with no rationale cannot be assessed as appropriate or inappropriate; it can only be assessed as incomplete.

Point (d) requires explicit cross-references into the clinical evaluation report and the risk management file. Not a general statement that PMCF supports clinical evaluation — a reference to the relevant parts. In practice this means naming the specific residual risks, the specific claims and the specific gaps in clinical evidence that PMCF is being run to address.

Point (f) requires an evaluation of clinical data relating to equivalent or similar devices. Note that it is broader than the equivalence test in Part A Section 3, which requires technical, biological and clinical equivalence to be demonstrated. Here similar devices are in scope too, without that demonstration. Data on similar devices cannot substitute for data on your own device, but the state of the art around it has to be watched.

Point (h) is where plans fail in operation rather than in drafting. The schedule has to be detailed and adequately justified, and the example given in the text is analysis of PMCF data and reporting. A plan that says PMCF data will be reviewed periodically has neither detail nor justification. A plan with named milestones, and a reason each interval is appropriate to the device's lifetime and risk, has both.

The evaluation report

Section 7 converts activity into a document. "The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report that shall be part of the clinical evaluation report and the technical documentation." (MDR Annex XIV, Part B, Section 7)

The report belongs in two places at once. Inside the clinical evaluation report, because PMCF updates the clinical evaluation. And inside the technical documentation, which means it is within the copy the authorised representative keeps available under Article 11(3)(a) and within what a competent authority can request.

The verb in Section 7 is analyse. A PMCF evaluation report that lists data collected without reaching conclusions about what it means for safety, performance and benefit-risk has documented the findings without analysing them.

The feedback obligation

Section 8 is the provision that gives PMCF consequences. "The conclusions of the PMCF evaluation report shall be taken into account for the clinical evaluation referred to in Article 61 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them." (MDR Annex XIV, Part B, Section 8)

Two obligations. The conclusions feed into clinical evaluation and into risk management — which means the clinical evaluation report and the risk management file should both show evidence of having been revised in light of PMCF, and a reviewer will look for that. And where PMCF identifies a need for preventive or corrective measures, implementation is mandatory. Not considered, not scheduled: implemented.

This is the clause that makes a PMCF programme risky to run badly. Data collected and not acted on is worse than data not collected, because the file then contains a documented signal with no documented response.

Where the authorised representative encounters it

Article 11(3)(a) requires the authorised representative to verify that the technical documentation has been drawn up and to keep a copy available. Because the PMCF plan sits in the post-market surveillance documentation and the PMCF evaluation report sits in both the clinical evaluation report and the technical documentation, both are within scope of what the representative holds and produces on request.

What is worth checking, and what is worth checking repeatedly rather than once:

That the plan contains specific methods under point (b), not only general ones — the structural test that takes a minute and catches the commonest defect.

That the schedule under point (h) has dates that have not already passed without a corresponding report.

That a PMCF evaluation report exists for each completed cycle, and that the clinical evaluation report shows it was incorporated.

That where the manufacturer has concluded PMCF is not appropriate for a device, a justification exists in the technical documentation rather than a silence.

That the PSUR's account of the main findings of the PMCF, required by Article 86(1), matches what the PMCF evaluation report actually says.

That where PMCF identified a need for corrective or preventive measures, those measures were implemented and the implementation is documented.

The last two are where an authorised representative adds something a filing system does not. A PSUR that reports no PMCF findings alongside a PMCF plan promising registry evaluation is an internal inconsistency visible from outside the company, and it is exactly the inconsistency a competent authority notices. Our guide to authorised representative liability covers the position the representative is in when the file it holds is internally inconsistent.

Practical points

Write the plan from the gaps, not from the methods. Start with the residual risks, the unsupported claims and the clinical evidence gaps identified in the clinical evaluation, then choose methods capable of closing them. A plan built the other way round — methods first, objectives retrofitted — will not survive point (c).

Set the horizon by expected lifetime. Objective (a) is explicit about it, and for long-lifetime devices this is the difference between a compliant programme and one that stops when the certificate is renewed.

Do not merge the PMCF plan into the post-market surveillance plan. They are linked but distinct, they have different mandatory contents, and a merged document usually satisfies neither list in full.

Give objective (e) a method. Off-label and systematic misuse detection needs something that can see how the device is being used — user surveys, registry indications data, distributor or clinical feedback structured to capture indication — not a statement that no off-label use is expected.

Keep the version chain visible. Plan version, report version, clinical evaluation report version and PSUR version should be traceable to each other, so a reviewer can see the cycle turning.

If you place devices on the EU market from outside the Union and want an authorised representative that reviews PMCF plans and reports against Annex XIV Part B on a schedule rather than once at onboarding, our authorised representative service covers clinical and post-market documentation across MDR portfolios.

Medex Kurumsal as your EU authorised representative

If you place medical devices or in vitro diagnostics on the European market from outside the Union, Article 11 of MDR 2017/745 — and Article 11 of IVDR 2017/746 for in vitro diagnostics — requires a single authorised representative established in a Member State before those devices reach the market. Medex Kurumsal Danismanlik acts as EU authorised representative under both Regulations, registered in EUDAMED under SRN TR-AR-000057550.

What the mandate covers: verification of the EU declaration of conformity and the technical documentation before signature rather than after; the Article 11(3)(a) copy of the file kept available for the full retention period; EUDAMED actor and device registration and the Basic UDI-DI submission; the registered EU address printed on your label and instructions for use; handling of competent authority requests, samples and information in the language of the Member State concerned; and the vigilance interface under Articles 87 to 90.

We review the file before accepting a mandate, because Article 11(5) makes the authorised representative jointly and severally liable for defective devices where the manufacturer has not complied with Article 10. A file we have not read is a liability we cannot price. Our fee structure is published on the EU authorised representative cost page, and the scope of the service is set out under EU authorised representative. Send us the declaration of conformity and the device list and we will tell you within two working days whether the file is ready for a mandate and what is missing if it is not.