What is Post-Market Clinical Follow-Up under the EU MDR?
Post-Market Clinical Follow-Up (PMCF) is a continuous, proactive process of collecting clinical data from the real-world use of a device after it is placed on the market. PMCF is required under the European Medical Device Regulation (EU MDR), defined in Annex XIV, Part B. It is a crucial part of your Post-Market Surveillance (PMS) system, which monitors a medical device’s safety and performance once it has been CE Marked and placed on the EU market. Data gathered through PMCF supports continuous clinical evaluation and must be incorporated into the device’s Technical Documentation and Clinical Evaluation Report (CER). It is also a vital component of your quality management system (QMS).
The primary goals of PMCF are to confirm the long-term safety and performance of the device, monitor the ongoing acceptability of known risks, identify any new risks or side effects, and ensure that the device's benefit-risk balance remains acceptable. PMCF also helps detect off-label use and verify that the device continues to be used as intended.
Planning your PMCF activities
The first step in the PMCF process is to develop a structured PMCF Plan. This document outlines the strategy and methods you will use to gather clinical data. PMCF data can include user surveys, literature reviews, registry data, or formal PMCF studies. You must explain why each method was selected and how it aligns with the specific safety and performance requirements for your device. The detailed structure and content of the PMCF Plan is published in MDCG 2020-7 “Post-market clinical follow-up (PMCF) Plan Template."
The scope of your PMCF activities should be proportionate to the device’s risk class and type. Manufacturers should perform a gap analysis to identify the clinical data they need, after the devices have been placed on the EU market. The PMCF Plan must include how to select appropriate data collection methods and sources and how to update risk management and CER accordingly. Manufacturers of lower-risk devices may justify limited or no PMCF activities in their PMCF Plan, provided they present sufficient rationale. High-risk devices typically require more comprehensive PMCF plans and PMCF studies to demonstrate the device’s safety and performance.
PMCF reporting requirements
Once implemented, the results of your PMCF activities will be summarized in a PMCF Report, which is part of your ongoing updates to the CER. For Class III and Class IIb implantable devices, the PMCF report should be updated annually. Other devices should update it every 2-5 years, depending on the device class, or as needed, if PMS data raises new questions or gaps regarding device safety and performance or suggests an emerging risk or side effect. PMCF data is also summarized in the PMS Report or Periodic Safety Update Report (PSUR), depending on your device class. The detailed content of the PMCF Report is published in MDCG 2020-8 “Post-market clinical follow-up (PMCF) Report Template."
