Start with what's necessary. Download our comprehensive PMCF cheat sheet and learn when, why, and how to implement post-market clinical follow-up under MDR.
Post-market clinical follow-up (PMCF) isn't always required for every medical device—but knowing when it is can save you months of regulatory delays and costly rejections. Here are the key signals that indicate you need to start planning your PMCF strategy.
When indications are novel
When significant changes are made to the product or intended use
When the design, invasiveness, or anatomical location increases risk
When there are long-term safety or performance questions
When literature, complaints, or prior investigations raise safety signals
When CE marking was based on equivalence
When expanding platforms across anatomies or populations
& many other scenarios...
Once the need for PMCF is identified, the next question is: how? A number of evidence-generating activities already exist and can be combined to build a robust PMCF strategy.
Controlled trials with predefined endpoints, follow-up schedules, and patient-reported outcomes (PROMs).
Long-term data collection over 2–10 years from national or international device registries.
Retrospective analysis of medical records with predefined endpoints and sampling criteria.
Recall-based or predefined sampling surveys to capture real-world patient and clinician feedback.
Systematic reviews of published long-term series and clinical studies for benchmarking.
Hybrid strategies that integrate multiple methods for comprehensive evidence generation.
Choosing the right PMCF endpoints is essential. For an orthopaedic implant, here's how endpoints evolve over time:
→ Wound issues
→ Infection rates
→ Dislocation events
→ Early complications
→ Pain levels
→ Mobility and range of motion
→ Radiographic outcomes
→ Patient-reported outcomes (PROMs) like HOOS or KOOS
→ Revision rates
→ Implant wear and migration
→ Mechanical failure
→ Long-term functional outcomes
Get instant access to our comprehensive PMCF guide. Learn when PMCF is required, which methods to use, and how to align your strategy with regulatory expectations under EU MDR.
