Post-Marketing Clinical Follow-up Studies (PMCF) in Europe
Our experience includes safety and performance studies and post-marketing clinical follow-up studies (PMCF). We can be your bridge to key opinion leaders and surgical experts from across Europe.
Post-Market Clinical Monitoring (PMCF) is an important part of ongoing regulatory compliance for medical devices in the EU.
You will most likely be required by Notified Bodies (NB) to conduct additional clinical research, called PMCF studies.
We can describe the PMS and PMCF studies in the context of the change from the current Medical Device Directive 93/42/EU (MDD) to the new Medical Device Regulation (MDR 2017/745/EU), as well as how the activities Current PMCFs can help your transition to the MDR.
Points to consider:
- How PMCF study requirements change under the MDR
- PMCF study requirements under the MDR
- The difference between a clinical investigation and a PMCF study
- Important considerations when conducting a PMCF study
