How do medical device manufacturers meet their PMCF obligations under the MDR, and what distinguishes PMCF from general post-market surveillance?
We build complete PMCF programs for medical device manufacturers, from the PMCF plan and the right study design (registries, surveys, retrospective analyses, literature supplementation) through to the PMCF evaluation report for the technical documentation. PMCF is not a standalone document: it is the proactive collection of clinical data within post-market surveillance, the results of which feed directly back into the update of the clinical evaluation. Anyone who writes the PMCF plan only after certification has already lost the evaluation period in which the data should have been generated.
- MedTech
Overview
Why is PMCF more demanding under the MDR than under the MDD?
PMCF programs across all risk classes · MDR (EU 2017/745) Annex XIV Part B, MDCG 2020-7, MDCG 2020-8
Last updated: 2026-06-13
The Medical Device Regulation (EU) 2017/745 turned PMCF from an optional activity into one that is generally mandatory. Clinical evidence no longer ends at certification but must be kept current across the entire lifecycle. The four points where manufacturers get stuck in practice:
- Annex XIV Part B requires a PMCF plan for every device, or a documented justification for why PMCF is not necessary in the specific case. The mere absence of a plan is already a non-conformity.
- PMCF must be planned proactively and must not wait reactively for vigilance signals. The data collection is a specific clinical activity within post-market surveillance under Art. 83–86, not the PMS system itself.
- The results of the PMCF feed into the periodic update of the clinical evaluation under Art. 61 and Annex XIV Part A. Without PMCF data, the clinical evaluation cannot be soundly maintained over time.
- For Class III devices and implantable devices, notified bodies scrutinize the PMCF plan and PMCF evaluation report particularly closely. Inadequate or missing PMCF activities are among the frequent major findings here.
Services
How we support you
PMCF plan & strategy
Device-specific PMCF plan per MDCG 2020-7 with general and specific objectives, a rationale for the chosen method as well as the definition of patient numbers, procedures and timeline. The result is a standalone plan document for the technical documentation under Annex III.
PMCF registries & surveys
Design and implementation of PMCF registries and user-based surveys: protocol, EDC system, site setup and patient consent. We deliver a ready-to-run study package including data collection forms for the clinical sites.
Retrospective analyses & literature supplementation
Structured retrospective analysis of existing clinical data from complaints, user feedback and PMS, as well as systematic literature supplementation as a PMCF method where a prospective collection is not required. The result is a traceable evidence base with a documented search strategy.
PMCF evaluation report
Preparation of the PMCF evaluation report per MDCG 2020-8: summary of the PMCF activities, clinical findings, conclusions and resulting actions required, ready to feed into the update of the clinical evaluation.
Learn more →How we work together
What it comes down to
Post-market clinical follow-up is not an activity that can be tacked on after certification. Under the Medical Device Regulation (EU) 2017/745, the clinical evaluation is a continuous process, and PMCF is the strand that supplies it with fresh data. The sequence is decisive: the clinical evaluation under Art. 61 identifies the open clinical questions. The PMCF plan under Annex XIV Part B determines the method by which those questions are answered. And only the ongoing data collection generates the material for the PMCF evaluation report. Anyone who skips one of these stages creates a break in the chain of evidence that the notified body reliably finds in the surveillance audit.
The real limiting factor is time, not the document. Registries, surveys and prospective studies per ISO 14155 need lead time for protocol, EDC system and the engagement of clinical sites before the first data point is generated. If the PMCF plan is written only shortly before the next cut-off date of the clinical evaluation, the period in which the data should have accrued is missing. We therefore start early: PMCF needs and method selection are derived from the open questions of the clinical evaluation before study design and site setup are commissioned, so that usable evidence is available by the cut-off date instead of a plan that has only just begun.
Our approach
Our approach
Step
Result
PMCF needs analysis
Assessment of which devices require PMCF and which open clinical questions from the clinical evaluation need to be addressed.
Strategy & method selection
Defined PMCF method per device (registry, survey, retrospective analysis, literature supplementation) with a documented rationale.
PMCF plan
Standalone PMCF plan per MDCG 2020-7, anchored in the technical documentation and the PMS plan.
Data collection
Set up and ongoing data collection with protocol, EDC system and engaged clinical sites.
PMCF evaluation report
Completed report per MDCG 2020-8 with conclusions and identified actions required.
Feedback into the clinical evaluation
Results fed into the update of the clinical evaluation under Art. 61, prepared for the surveillance audit.
Common pitfalls
Where projects commonly fail
The PMCF plan is missing entirely, and there is also no justification for why PMCF is not required.
Annex XIV Part B requires one of the two for every device, so the simple absence is already a non-conformity in the audit.
PMCF is equated with PMS.
A PMS plan does not replace a PMCF plan: PMS is the overarching system under Art. 83–86, PMCF the specific proactive collection of clinical data within it. Anyone who submits only a PMS document has not met the PMCF obligation.
The PMCF evaluation report is written but never fed back into the clinical evaluation.
Without this link to the update under Art. 61, the clinical evaluation remains outdated, and the notified body spots the break in the chain of evidence.
The PMCF method does not match the open clinical questions.
Literature supplementation alone does not cover the long-term risks of an implant; the rationale for the chosen method per MDCG 2020-7 must match the specific objectives, otherwise it falls short.
PMCF is not started until after certification.
Data collection needs lead time for protocol, EDC and site setup; anyone who starts too late has no usable data by the cut-off date of the next clinical evaluation update.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR): primary text, Art. 61, 83–86, Annex III, Annex XIV Part A and Part B
- MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template
- MDCG 2020-8: Post-market clinical follow-up (PMCF) Evaluation Report Template
- ISO 14155: Clinical investigation of medical devices for human subjects
- Source material: pmcf-post-market-clinical-follow-up.md (writer output, revised)
- https://theentourage.de/clinical-medical-affairs/post-market-clinical-follow-up-pmcf/
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- MDR Annex XIV Part B (Post-Market Clinical Follow-up)
- MDR Annex III (Technical documentation on post-market surveillance)
- MDR Annex XIV Part A (Clinical evaluation)
- MDR Art. 61 (Clinical evaluation)
- MDR Art. 83–86 (Post-market surveillance)
- MDCG 2020-7 (PMCF plan template)
- MDCG 2020-8 (PMCF evaluation report template)
- ISO 14155 (Clinical investigation of medical devices for human subjects)
- ISO 14971 (Risk management)
Related topics
Post-Market Surveillance →
The overarching PMS system under MDR Art. 83–86 in which PMCF is embedded
Clinical Evaluation →
Update of the clinical evaluation under Art. 61 with PMCF data
Clinical Project Management →
Study and project management for PMCF registries and surveys
Medical Writing →
Preparation of the PMCF plan and PMCF evaluation report
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