Clinical Affairs
Post-Market Clinical Follow-Up (PMCF)
Through the MDR, the surveillance of medical devices is becoming increasingly important. This does not only require a functional PMS system; clinical safety must also be monitored. Curtain up for post-marketing clinical follow-up.
The PMCF is often integrated into the parent Post-Market Surveillance (PMS) process. But the PMCF is in no way less important. While the PMS concentrates on all types of feedback, PMCF actively collects clinical data. Meaning that the P in PMCF does not only stand for Post-market, but for Proactive.
The clinical evaluation
is now done – what now?
But what is the goal of the PMCF? Annex XIV from the MDR describes the post-market clinical follow-up as an “continuous process that updates the clinical evaluation”. All data that is collected during the PMCF process must be evaluated; the result is then found in the clinical evaluation report. Thus, post-marketing clinical follow-up continuously confirms the clinical safety and performance of products in the field.
Without proof of clinical safety and performance, the authorization to distribute the products is no longer valid!
If the Post-Market Surveillance still does not work properly, the issues will follow into the post-market follow-up. Not necessarily! Even though both may sound very similar, and address similar topics, they are not interchangeable.
The engine for clinical evaluation
One can imagine the PMCF as the engine that keeps the clinical evaluation running. The clinical evaluation report is updated regularly (depending on the risk class that the medical device has). These periods between updates are, however, only to be understood as a minimum requirement. The CER also requires updates based on new findings that affect safety and performance. And it is precisely these findings that a PMCF process can provide.
The PMCF is an indispensable part of a company
The Post-Market Clinical Follow-Up is mandatory for all manufacturers - independent from the risk class. Even Class I devices require a clinical evaluation and a PMCF-process. Just like all processes, it must be:
- Planned
- Organized
- Documented
- Applied
- Updated regularly
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Regulatory Affairs Update 25/23
Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23
