$347 — Premium Tier

EU MDR PMCF Toolkit: Post-Market Clinical Follow-up Templates

EU MDR PMCF Toolkit — PMCF plan template, evaluation report, literature search protocol, clinical data gap analysis, study protocol, and PMS integration guide.

Get the Toolkit — $347

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What's Included

PMCF Plan Template (EU MDR Annex XIV Part B)
PMCF Evaluation Report Template (EU MDR Article 61(11))
Literature Search Protocol for PMCF
Clinical Data Gap Analysis Worksheet
PMCF Study Protocol Template
Post-Market Surveillance to PMCF Integration Guide

Benefits

PMCF plan aligned with Annex XIV Part B requirements
Evaluation report template meets Article 61(11) obligations
Systematic literature review protocol satisfies notified body methodology requirements
Clinical data gap analysis identifies evidence gaps before NB review

Is This For You?

This toolkit is designed for teams facing these challenges:

Notified body rejecting PMCF plan as insufficiently robust
No systematic literature review protocol documented
Clinical data gaps not formally identified
PMCF and PMS activities treated as separate disconnected processes

Who This Is For

RA managers responsible for CE marking renewalClinical affairs leads managing post-market clinical evidenceCompanies transitioning from MDD to EU MDRNotified body audit preparation teams

Frequently Asked Questions

Is PMCF required for all EU MDR devices?

Yes, EU MDR Article 61 requires PMCF for all devices unless justified in the clinical evaluation plan. Class IIa, IIb, and III devices have the most stringent PMCF requirements.

What is the difference between PMCF and PMS?

PMS (Post-Market Surveillance) is the overall system for collecting and analyzing post-market data. PMCF is the clinical component — proactive clinical data collection activities specifically to confirm safety, performance, and benefit-risk profile.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $347

7-day money-back guarantee