The PMCF Decision Guide

Proposed changes to the EU MDR could eliminate the standalone post-market clinical follow-up (PMCF) evaluation report and relax reporting cadences. The proposal shifts the question from which report to write to which evidence gap remains and which method closes it without weakening traceability. Notably, the mandate to proactively collect and evaluate clinical data under Annex XIV Part B remains. The paper builds method-selection logic around a defined clinical uncertainty, supplies model Section 6.2(c) justification language, and works through a drug-eluting coronary stent example. It also benchmarks PMCF data-capture cost from first principles across three operating models, and sets out a 90-day path to a defensible approach, with appendices on notified body dossiers, vendor due diligence, and GDPR. Examine the analysis to see where the cost actually sits.