A PMCF evaluation report under MDR is the document that summarises the clinical data collected through the PMCF plan, appraises it against the pre-specified objectives and acceptance criteria, and states what the findings mean for the clinical evaluation report, the risk management file, the labelling, and the benefit-risk determination. Annex XIV Part B of Regulation (EU) 2017/745 requires the manufacturer to analyse the findings of the PMCF and document the results in a PMCF evaluation report that is part of the clinical evaluation report and the technical documentation. Article 61(11) ties the report to the clinical evaluation update cycle, and Article 86 ties it to the Periodic Safety Update Report for Class IIa, IIb, and III devices.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • The PMCF evaluation report is the output document required by Annex XIV Part B Section 7 of Regulation (EU) 2017/745. It reports what the PMCF plan actually produced, not what it intended to produce.
  • The report is part of the clinical evaluation report and part of the technical documentation. It is not an optional annex.
  • Article 61(11) names the PMCF evaluation report as the input to the clinical evaluation update cycle, and Article 86 names the PMCF findings as a mandatory element of the PSUR for Class IIa, IIb, and III devices.
  • A compliant report follows a recognisable structure: restate the plan, summarise activities performed, present the data, appraise against pre-specified acceptance criteria, analyse against the Annex XIV Part B objectives, and state the conclusions and the actions that follow.
  • The conclusion paragraph is the load-bearing element. It either documents a CER update, a risk file update, a labelling change, a corrective action, or a reasoned decision that no update is required. A report that ends without a conclusion has broken the Article 61(11) loop.
  • MDCG 2025-10 (December 2025) is the current operational guidance on how PMCF fits inside the PMS system and is the document to read alongside the Annex when drafting the report.

Where this post sits in the PMCF cluster

Post 181 is the pillar on post-market clinical follow-up under MDR. Post 182 walks through how to write the PMCF plan under Annex XIV Part B. Post 184 covers how to design a prospective PMCF study. This post is the one in the middle of the lifecycle: the report that closes the loop by taking the data the plan produced and turning it into documented updates to the clinical file. If the plan is the commitment and the study is one method, the evaluation report is the delivery. It is the document a notified body auditor will read most carefully during surveillance of higher-class devices, because it is where the clinical feedback loop either demonstrably runs or visibly does not.

The purpose of the PMCF evaluation report

The PMCF evaluation report exists to convert post-market clinical data into documented clinical decisions. Annex XIV Part B defines PMCF as a continuous process that updates the clinical evaluation referred to in Article 61 and Annex XIV Part A. The plan specifies how the data will be collected. The report specifies what the data said and what it changed. Without the report, PMCF is just data collection. With the report, PMCF is a functioning clinical feedback loop.

The report is also the artefact that carries the findings out of the PMCF silo and into every other clinical-file document that has to reflect the current clinical picture of the device. The CER cannot be updated under Article 61(11) without a PMCF evaluation report to draw from. The PSUR required by Article 86 for Class IIa, IIb, and III devices cannot state the main findings of the PMCF without a report that contains them. The Summary of Safety and Clinical Performance required for Class III and implantable devices cannot reflect current clinical data without the same source. The report is the hub document for post-market clinical information, and the downstream documents are the spokes that depend on it.

A report written well makes every downstream update simpler. A report written badly — narrative without analysis, or numbers without conclusions — forces the downstream documents to improvise, and improvisation at audit is where non-conformities are written.

Required content per Annex XIV Part B Section 7

Annex XIV Part B Section 7 of Regulation (EU) 2017/745 is the provision that requires the manufacturer to analyse the findings of the PMCF and document the results in a PMCF evaluation report. The Annex does not prescribe a rigid template — it does not tell you which sections to number or which headings to use. It does tell you, through the surrounding text of Annex XIV Part B and through the cross-references in Article 61(11) and Article 86, what the report must contain to serve its purpose.

A compliant PMCF evaluation report addresses the following content, regardless of the heading structure used.

Restatement of the PMCF plan. The report references the PMCF plan it is reporting against, summarises the general and specific methods the plan committed to, the Annex XIV Part B objectives each activity was meant to address, and the pre-specified acceptance criteria from the plan. Without this anchor, the findings cannot be compared to anything.

Summary of PMCF activities actually performed. The report describes the activities that ran during the reporting period — the literature searches performed, the surveys administered, the registry data extracted, the PMCF studies conducted, the similar-device monitoring done. Any deviation from the plan — an activity that did not run, a cadence that slipped, a method that was changed — is noted explicitly with the reason and the impact on the data.

Presentation of the data collected. The report presents the data, organised by source and method. Quantitative data in tables where tables are appropriate; qualitative data summarised without losing the signal. Data sources are cited, dates are specified, and any limitations on the data are stated in the same place the data is presented, not hidden in a footnote.

Appraisal against pre-specified acceptance criteria. The report compares the data against the acceptance criteria from the PMCF plan. Did the observed adverse event rate exceed the threshold? Did the clinical performance measure stay within the expected range? Did the similar-device monitoring reveal a signal relevant to this device? The appraisal is mechanical where the criteria were pre-specified, and it is defensible because the criteria were written in advance, not invented after the data arrived.

Analysis against the Annex XIV Part B objectives. The report analyses the findings against each of the PMCF objectives named in Annex XIV Part B: whether the clinical safety and performance remain consistent with the clinical evaluation throughout the expected lifetime of the device, whether any previously unknown side-effects have emerged, whether identified side-effects and contraindications are occurring at frequencies and severities consistent with the risk management file, whether the benefit-risk ratio referred to in Sections 1 and 9 of Annex I remains acceptable, and whether any systematic misuse or off-label use has been identified. Each objective gets a paragraph. No objective is skipped.

Conclusions and actions. The report states the conclusions of the analysis and names the specific actions that follow. This is the element discussed in its own section below, because it is where most reports fall short.

References and supporting documentation. The report references the PMCF plan, the current CER, the risk management file under EN ISO 14971:2019 + A11:2021, any PMCF clinical investigation reports produced under EN ISO 14155:2020 + A11:2024, MDCG 2025-10 as the operational guidance consulted, and any other documents the reader needs to verify the analysis.

The report is part of the clinical evaluation report and part of the technical documentation. It is not a memo and not an internal working document. It is signed, dated, versioned, and held to the same standard as every other controlled document in the technical file.

Article 86 of Regulation (EU) 2017/745 requires manufacturers of Class IIa, Class IIb, and Class III devices to prepare a Periodic Safety Update Report for each device and, where relevant, for each category or group of devices, summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. Article 86 also requires the PSUR to state the main findings of the post-market clinical follow-up referred to in Annex XIV Part B.

That cross-reference is the operational link between the PMCF evaluation report and the PSUR. The PSUR is not a separate clinical analysis. It is a surveillance document that relies on the PMCF evaluation report as one of its primary inputs. The main findings of the PMCF — the conclusions, the trends, the signals, the actions — flow from the PMCF evaluation report into the PMCF section of the PSUR, and the PSUR then sits inside the PMS system alongside the PMS Report required by Article 85 for Class I devices.

For Class III and implantable devices, the PSUR is updated at least annually and submitted to the notified body. For Class IIa and Class IIb devices, the cadence is specified by Article 86 and proportionate to the class. In every case, the PMCF evaluation report cadence must be at least as frequent as the PSUR cadence, because a PSUR cannot cite findings from a report that does not yet exist.

For the walkthrough of the PSUR structure and how the PMCF findings populate it, see the post on the PSUR under MDR Article 86. For the broader relationship between PMS, PMCF, vigilance, and the clinical evaluation cycle, see what is post-market surveillance under MDR and MDR Articles 83 to 86 — the PMS framework explained.

The conclusion paragraph

The conclusion paragraph of the PMCF evaluation report is the load-bearing element. Every preceding section exists to support it. If the conclusion is weak, vague, or missing, the report has failed regardless of how thorough the preceding sections look.

A compliant conclusion paragraph does four things, explicitly.

It states whether the clinical safety and performance of the device remain consistent with the clinical evaluation. This is not a rhetorical flourish. It is a documented finding, supported by the data and the appraisal in the earlier sections of the report. Consistent or not consistent. Both answers are legitimate; no answer is not.

It states whether the benefit-risk ratio remains acceptable. Annex I Sections 1 and 9 frame the benefit-risk determination the device was CE marked against. The conclusion paragraph reaffirms that determination against the new evidence, or flags that the new evidence has moved the ratio enough to require re-evaluation.

It names the specific actions that follow. An update to the CER under Article 61(11). An update to the risk management file under EN ISO 14971:2019 + A11:2021. A change to the IFU or labelling. A corrective action under the CAPA system. An update to the SSCP for Class III and implantable devices. A field safety corrective action where the findings warrant it. Or — legitimately — a reasoned decision that no update is required, with the reasoning written out and referenced to the data. "No action" without reasoning is not a conclusion; "no action because the observed rates are within the pre-specified acceptance criteria and no new signals were detected" is.

It names the cadence of the next PMCF evaluation report and any plan revisions. If the next report is due in twelve months and the plan itself needs revision based on the current findings, both are stated here. The conclusion is forward-pointing as well as backward-pointing.

A conclusion that does these four things produces a report that closes the loop cleanly. A conclusion that does not produces a report the notified body auditor will press on until one of the four is supplied, usually in the middle of a surveillance audit where the pressure is highest.

Common mistakes

Six mistakes recur across startup PMCF evaluation reports.

Writing the report as narrative instead of analysis. The report describes activities and lists data but never appraises the data against the pre-specified acceptance criteria. Without the appraisal, the report is a log, not an evaluation.

Omitting one or more Annex XIV Part B objectives. The five PMCF objectives in Annex XIV Part B are the test the report must pass. A report that analyses safety and performance but says nothing about systematic misuse, or that monitors identified risks but never checks the benefit-risk ratio, has a gap a notified body auditor will find quickly.

Disconnecting the report from the CER update. The whole point of PMCF is to keep the CER current under Article 61(11). A report that does not produce a documented CER update, or a documented reasoned decision that no update is needed, has broken the loop.

Leaving the conclusion paragraph vague. "The device continues to perform safely" is not a conclusion. The conclusion paragraph must state explicit findings, explicit actions, and explicit cadences.

Not linking to the PSUR. For Class IIa, IIb, and III devices, the PSUR under Article 86 relies on the PMCF evaluation report as an input. A report that is not written with the PSUR consumer in mind forces the PSUR author to reconstruct the findings later, and reconstruction introduces errors.

Producing the report on a cadence slower than the PSUR cadence. A PSUR cannot cite findings from a report that has not been produced yet. The PMCF evaluation report cadence must match or exceed the PSUR cadence, and the PMCF plan time schedule must reflect that.

The Subtract to Ship angle

The Subtract to Ship framework for MDR applied to the PMCF evaluation report produces a short rule. Every paragraph in the report must trace to one of three targets: an Annex XIV Part B Section 7 content requirement, an Annex XIV Part B objective, or a specific CER section or risk file entry the findings are meant to update. Paragraphs that trace to none of those targets are narrative filler and should be cut.

The report that results is lean. It restates the plan, summarises the activities, presents the data, appraises against pre-specified criteria, analyses against the Annex XIV Part B objectives one by one, states the conclusions and the actions, and stops. It is short enough to be readable, structured enough to be auditable, and explicit enough that every downstream document — the CER update, the PSUR, the SSCP — can draw from it without improvisation. Minimum real beats elaborate fictional, and the fastest way to a report that actually closes the loop is to cut every sentence that does not help it close.

Reality Check — where do you stand?

  1. Does your PMCF evaluation report address every content element that Annex XIV Part B Section 7 implies — restatement of the plan, activities performed, data presented, appraisal against acceptance criteria, analysis against the Annex XIV Part B objectives, and explicit conclusions?
  2. For each Annex XIV Part B objective, does the report contain a paragraph that analyses the findings against that specific objective?
  3. Were the acceptance criteria that the report appraises against pre-specified in the PMCF plan, or were they invented after the data arrived?
  4. Does the conclusion paragraph state explicit findings, explicit actions, and an explicit cadence for the next report?
  5. If the conclusion is "no update required," is the reasoning written out and referenced to the data, or is it a bare assertion?
  6. Does the report cadence match or exceed the PSUR cadence required by Article 86 for the device class?
  7. When the next PSUR is drafted, will the PMCF findings flow from the report directly into the PSUR section on PMCF, or will the PSUR author have to reconstruct them?
  8. Has the report been reviewed against the current CER and the risk file, so any updates triggered by the findings are implemented and documented?

Frequently Asked Questions

What is the difference between the PMCF plan and the PMCF evaluation report?

The PMCF plan is written before CE marking and specifies what will be done. The PMCF evaluation report is produced as the plan runs and documents what actually happened, what the findings mean for the clinical evaluation, the risk file, the labelling, and the benefit-risk determination, and what actions follow. The plan is the commitment; the report is the delivery.

How often must the PMCF evaluation report be produced?

The cadence is specified in the PMCF plan and is proportionate to the risk class, the novelty of the device, and the clinical evaluation update cycle. For Class III and implantable devices, Article 61(11) requires the clinical evaluation to be updated at least annually with PMCF data, which means the PMCF evaluation report runs on at least an annual cadence for those classes. For Class IIa and IIb devices, the cadence is justified in the plan and must be at least as frequent as the PSUR cadence required by Article 86.

Is the PMCF evaluation report a standalone document or part of the CER?

Annex XIV Part B states that the PMCF evaluation report is part of the clinical evaluation report and the technical documentation. In practice, manufacturers often maintain it as a physically separate document that is referenced from the CER and bundled into the technical file at submission. Either form is acceptable provided the link is clear and the content requirements are met.

What happens if the PMCF evaluation report concludes that no update is required?

A reasoned "no update required" conclusion is legitimate if it is supported by the data and the appraisal, and if the reasoning is written out. It must state that the observed findings are within the pre-specified acceptance criteria, that no new signals were detected, that the benefit-risk ratio remains consistent with the current CER, and that the next report is scheduled for a specific date. A bare "no action" statement without reasoning is not a valid conclusion.

How does the PMCF evaluation report feed the PSUR?

Article 86 requires the PSUR for Class IIa, IIb, and III devices to state the main findings of the post-market clinical follow-up referred to in Annex XIV Part B. The PMCF evaluation report is the source document for those findings. The PSUR author reads the report, summarises the main findings, conclusions, and actions in the PMCF section of the PSUR, and references the PMCF evaluation report as the source. The report must therefore be produced on a cadence at least as frequent as the PSUR and must be written so the findings can be extracted cleanly.

Does the PMCF evaluation report need to reference MDCG 2025-10?

MDCG 2025-10, published in December 2025, is the current operational guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices, and it describes how PMCF fits inside the broader PMS system. The report does not have to cite the guidance in every section, but referencing it as the operational guidance consulted demonstrates that the manufacturer is current with MDCG practice and strengthens the report at notified body review.

Can a PMCF evaluation report be rejected by a notified body?

Yes. A notified body reviewing the technical file during surveillance can raise non-conformities against a PMCF evaluation report that is missing required content, that analyses the data inadequately, that does not appraise against pre-specified acceptance criteria, or that fails to produce a documented CER update or a reasoned decision that no update is needed. Non-conformities of this type are common and, at surveillance audits of Class III and implantable devices, are among the findings notified bodies raise most frequently.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 61(11) (PMCF update of clinical evaluation), Articles 83 to 86 (post-market surveillance system, plan, PMS Report, and PSUR), Annex I Sections 1 and 9 (benefit-risk determination within the general safety and performance requirements), Annex XIV Part A (clinical evaluation), and Annex XIV Part B including Section 7 (post-market clinical follow-up and the PMCF evaluation report). Official Journal L 117, 5.5.2017.
  2. MDCG 2025-10 — Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices. Medical Device Coordination Group, December 2025.
  3. EN ISO 14155:2020 + A11:2024 — Clinical investigation of medical devices for human subjects — Good clinical practice.
  4. EN ISO 14971:2019 + A11:2021 — Medical devices — Application of risk management to medical devices.

This post is part of the Post-Market Surveillance & Vigilance series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. A PMCF evaluation report is the document where post-market clinical data becomes documented clinical decisions, and the gap between a report that logs the activity and a report that actually closes the Article 61(11) loop is where most of the real audit risk lives.