Understanding Post-Market Clinical Follow-up Requirements
PMCF is a systematic collection and analysis of clinical data on marketed medical devices to verify or identify any adverse effects and monitor device performance in real-world conditions.
Mandatory under EU MDR for most medical devices. Required to demonstrate ongoing safety and clinical performance throughout the device lifecycle and support CE marking maintenance.
Provides competitive advantage through real-world evidence, supports market expansion, enables device improvements, and demonstrates commitment to patient safety and regulatory compliance.
To confirm safety and performance throughout your device’s expected lifetime, PMCF activities aim to:
Verify that the device continues to meet its intended purpose under normal conditions of use.
Detect previously unknown side-effects and monitor the acceptability of identified risks.
Generate data to support Post Market Surveillance (PMS) and Clinical Evaluation Report (CER).
Your PMCF Plan should include both general and specific activities with clear objectives.
What data do you need to generate? Are your methods appropriate? Consider all PMCF activity options to answer these questions.
The aims of collecting real-world evidence as part of PMCF activities:
Watch our expert-led webinar and discover how to design, implement, and optimize your PMCF activities under the MDR. Get notified body feedback, survey methodology insights, and actionable strategies for successful post-market clinical follow-up.
Watch the ReplayOvercome common obstacles in PMCF survey implementation with strategic planning.
Manufacturers struggle to pinpoint exactly what clinical data is missing from their PMCF documentation and how surveys can fill those gaps.
Review your PMCF plan and Clinical Evaluation Report to identify specific data gaps. Align survey objectives and questions directly with these gaps to ensure meaningful data collection.
→ Maintain clear focus to feed appropriate data into your PMCF activities.
Post-market data needs change over time as new safety signals emerge or regulatory expectations evolve.
Plan for multiple surveys over time as part of your ongoing PMCF plan development. Conduct periodic gap analyses to identify new data needs and adapt survey design accordingly.
→ Build flexibility into your PMCF strategy for continuous improvement.
Low response rates and incomplete or biased responses can compromise the validity of survey data.
Use validated questionnaires, keep surveys concise, and leverage user-friendly ePRO platforms. Implement reminder systems and offer incentives where appropriate to boost response rates.
→ MILO's ePRO platform ensures GDPR compliance and data traceability.
Answers to the most common questions about PMCF planning and execution.
Requirements audit, risk analysis, plan drafting, method selection, implementation, data analysis, submission to authorities.
Surveys, registries, observational studies, RWE collection, incident analysis, literature review, user interviews.
Our team follows the latest MDCG and MEDDEV guidance and adapts each plan to the specific expectations of notified bodies.
Depending on device complexity, drafting and validation usually takes 2 to 6 weeks, excluding data collection.
