Post-Market Clinical Follow-up (PMCF) is the continuous process of collecting and evaluating clinical data on a medical device after it has received CE marking and is in real-world use. Under the EU Medical Device Regulation (EU) 2017/745 (MDR), the purpose is to confirm the device remains safe and performs as intended across its entire lifecycle.
PMCF sits inside the broader Post-Market Surveillance (PMS) system. PMS covers all activities for monitoring a device on the market. PMCF is the part that focuses specifically on Clinical data: gathering real-world evidence, identifying new risks or side effects, and confirming the device maintains a favorable benefit-risk profile.
PMCF activities include:
Manufacturers are required to include a PMCF plan in their PMS plan, under MDR Article 61 and Annex XIV Part B. Findings must be analyzed and documented in a PMCF evaluation report, which feeds the clinical evaluation and the technical documentation. Results may in turn drive updates to risk management documentation, the PMS plan, and the Summary of Safety and Clinical Performance (SSCP).
Per MDCG 2020-8 guidance, PMCF is not optional. It is central to maintaining CE marking and protecting patient safety.
A PMCF plan is designed to:
PMCF is more than a regulatory obligation. Done well, it strengthens your clinical evidence and surfaces real-world signals early enough to act on, safeguarding both compliance and patient outcomes throughout the device's life.
Navigating PMCF under MDR can be complex. Qserve helps medical device manufacturers design and implement effective PMCF strategies that are compliant, practical, and matched to your device and risk profile, whether you're updating a clinical evaluation or building a PMCF plan from scratch.
Want to strengthen your clinical evidence and stay compliant under MDR? Explore our PMCF services or get in touch with our team.