Post-Market Clinical Follow-Up (PMCF) and EU MDR

Galen Data Medical Device Innovation Webinar Series Presents:   

Post-Market Clinical Follow-Up (PMCF) and EU MDR  

Description:  The European Medical Devices Regulation (EU MDR) is a new set of regulations that govern medical devices’ production and distribution in Europe. The EU MDR requires more stringent clinical evidence for medical device manufacturers than previous guidance. As a result, many medical device manufacturers will need to collect more evidence via clinical investigations or other post-market clinical follow-up (PMCF) activities to obtain and renew their CE Mark certifications.  

Discussion Topics: 

The PMCF plan and general vs. specific PMCF activities 

Which PMCF activities can be relevant?