EU MDR requires active PMCF — most manufacturers have a plan that would not survive a notified body audit.
Instant download. For RA managers and clinical affairs teams at EU MDR-regulated device companies.
Notified bodies are rejecting PMCF plans that lack specificity. The most common deficiency findings:
This toolkit gives you the plan template, the literature protocol, the gap analysis, and the integration guide — everything needed for PMCF that holds up under notified body review.
From PMCF planning through evaluation reporting and PMS integration.
Complete PMCF plan aligned with EU MDR Annex XIV Part B requirements. Covers clinical objectives, PMCF activities (literature review, registry studies, surveys), endpoints, timelines, and reporting triggers. Structured to satisfy notified body scrutiny during technical documentation review.
Structured report template for documenting PMCF results per Article 61(11) and MDCG 2020-7. Covers analysis methodology, clinical data summary, benefit-risk conclusions, and required updates to clinical evaluation. Designed to integrate directly into your CER update cycle.
Systematic review methodology for post-market clinical literature monitoring. Covers database selection (PubMed, Embase, Cochrane), search string construction, inclusion/exclusion criteria, PRISMA flow documentation, and critical appraisal frameworks. Built for repeatability and audit defensibility.
Structured framework for identifying and documenting gaps between your current clinical evidence and EU MDR requirements. Maps clinical claims to supporting data, flags insufficient evidence, and prioritizes PMCF activities to close gaps before notified body review.
Observational study design template for device-specific PMCF studies. Covers study objectives, population selection, endpoints, sample size rationale, data collection procedures, statistical analysis plan, and ethics/regulatory considerations. Aligned with MEDDEV 2.12/2 rev 2 and ISO 14155.
Practical guide for connecting PMS and PMCF activities into a coherent post-market system. Covers data flow from vigilance, complaints, and PSUR into PMCF planning, trigger definitions for PMCF updates, and documentation structure to demonstrate the integrated system notified bodies expect.
The #1 notified body finding on PMCF plans: activities are listed but not systematic. The literature search protocol and study templates give you reproducible, auditable methods that demonstrate scientific rigor.
Identify clinical evidence gaps before your notified body does. The gap analysis worksheet maps every clinical claim to supporting data and flags exactly where PMCF activities need to focus.
EU MDR requires an integrated post-market system — not isolated activities. The integration guide shows you how to connect PMS signals to PMCF planning with clear data flows and trigger definitions.
“We built these templates during our MDR transition for a Class IIb implantable device. Our notified body reviewer specifically commented that the PMCF plan was one of the most complete they had seen. These are the exact frameworks we use at AB Medical for every CE marking submission.”
Joshua Millage, CEO — AB Medical Technologies
“The gap analysis worksheet alone saved us months of back-and-forth with our notified body. We identified three critical evidence gaps before submission that would have triggered a deficiency letter. These templates reflect what reviewers actually expect to see.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
Post-Market Surveillance (PMS) is the broad system for collecting and evaluating post-market data — complaints, vigilance, literature, registries. PMCF is the clinical subset: proactive, planned clinical activities to confirm safety and performance throughout the device lifetime. PMS feeds into PMCF, and PMCF results feed back into the clinical evaluation. EU MDR requires both, and notified bodies expect to see how they connect.
Notified bodies look for specificity and scientific rigor. Generic statements like "we will monitor literature" get flagged. They want to see: defined search strings and databases, specific clinical questions tied to your device, measurable endpoints, timelines, sample size rationale for studies, and clear criteria for when PMCF findings trigger a CER update. The templates in this toolkit are structured around these expectations.
Yes. EU MDR Article 61(11) requires PMCF for all devices regardless of clinical history. Even well-established devices need a PMCF plan — though the scope and intensity of activities can be proportionate to risk class and available evidence. A legacy device with extensive clinical data may need a lighter PMCF plan, but "no PMCF needed" is not an acceptable conclusion under MDR.
No. This is a practitioner reference toolkit. Consult your regulatory counsel and notified body for formal compliance opinions specific to your device.
EU MDR guidance, notified body updates, and compliance intel — delivered daily by RegWatch Daily.
Six documents. Instant download. EU MDR Annex XIV Part B + Article 61(11).