PMS Briefings #7: Post-Market Clinical Follow-Up (PMCF) – How to Ensure Continuous Clinical Safety
Welcome back to PMS Briefings! Following last week's exploration of Trend Reporting, this issue dives into another key pillar of MDR compliance: Post-Market Clinical Follow-Up (PMCF).
PMCF is a fundamental process that continuously verifies the safety and clinical performance of medical devices throughout their lifetime, protecting patient safety and maintaining regulatory compliance.
What is PMCF and Why is it Essential?
PMCF, as defined in the EU Medical Device Regulation (MDR 2017/745), is a systematic and proactive method for continuously collecting and analyzing clinical data on a medical device after market launch. It confirms that the device remains safe and effective when used as intended, identifies potential risks early, and validates ongoing benefit-risk assessments.
MDR Article 61(11) emphasizes the mandatory nature of PMCF:
"Manufacturers shall proactively collect and evaluate clinical data [...] to confirm the safety and performance throughout the expected lifetime of the device."
MDR Requirements for PMCF (Annex XIV Part B):
Manufacturers must clearly outline their PMCF activities within their PMS system, specifying the following:
Objectives: Clearly state clinical questions or uncertainties PMCF aims to address.
Methodology: Define specific methods used (clinical studies, surveys, patient registries, literature reviews).
Timelines: Include clear timing for data collection, analysis, and updates.
Roles and Responsibilities: Specify who manages PMCF activities and data analysis.
Common PMCF Activities Under MDR:
Prospective Clinical Studies: Conduct structured studies following device commercialization, collecting systematic clinical data.
Retrospective Data Analysis: Use hospital or registry data to evaluate long-term outcomes and performance in real-world settings.
Patient or Healthcare Professional Surveys: Collect structured feedback on device usage, performance, and safety.
Literature Reviews: Regular searches and analyses of scientific literature to identify new clinical data related to your device or similar devices.
Device Registries: Collaborate with national or international device registries to track outcomes for specific device categories (e.g., implants).
How to Develop an MDR-Compliant PMCF Plan:
Your PMCF plan should follow a structured format and cover:
General Device Information: Clearly identify the device, intended purpose, and indications.
Objectives and Justification: Explicitly state why PMCF is necessary and what clinical evidence gaps it addresses.
Methods of Clinical Data Collection: Outline detailed procedures, sources, and frequency of data collection.
Evaluation Methods: Explain how collected data will be analyzed, evaluated, and incorporated into PMS documentation.
Timelines and Milestones: Provide clear timing for initiating PMCF activities, data analysis, and reporting intervals.
Practical Tips for Effective PMCF Implementation:
Clearly define your PMCF goals based on clinical evaluation gaps identified pre-market.
Involve clinical experts early to ensure methods and data collected are clinically relevant.
Ensure seamless integration of PMCF outcomes into Clinical Evaluation Reports (CERs) and Risk Management documentation.
Utilize standardized templates (e.g., MDCG 2020-7 and MDCG 2020-8) for consistent documentation.
Official Resources to Guide Your PMCF Activities:
EU MDR (2017/745) – Annex XIV Part B: PMCF Access MDR Regulation
MDCG 2020-7: PMCF Plan Template Access MDCG 2020-7
MDCG 2020-8: PMCF Evaluation Report Template Access MDCG 2020-8
Common PMCF Pitfalls (and How to Avoid Them):
Insufficient Justification for No PMCF: Clearly document the scientific and regulatory rationale if PMCF is deemed unnecessary.
Delayed or Poorly Documented Activities: Implement clear PMCF timelines, assign accountability, and regularly audit documentation.
Inadequate Data Integration: Actively feed PMCF results back into your CER and risk management activities, ensuring continuous device safety improvement.
MDR Insight Quote (MDR, Annex XIV, Part B):
"The PMCF shall be understood to be a continuous process that updates the clinical evaluation [...] and shall be addressed in the manufacturer's post-market surveillance plan."
This highlights PMCF as a dynamic, integral part of your overall PMS framework, not simply a one-off task.
Coming Next Week:
In next week’s issue, PMS Briefings #8, we will explore how to effectively integrate PMS Data into Risk Management, highlighting best practices to keep your risk management processes continuously up-to-date and compliant.
Stay compliant and informed!
Immanuel