Post-market Clinical Follow-up (PMCF) is an important part of ongoing medical device regulatory compliance in the EU. PMCF can sometimes require you to conduct additional clinical investigations, called PMCF studies.
This white paper focuses on Post-Market Clinical Follow-up, and, more specifically, on PMCF studies. It will discuss PMCF and PMCF studies in the context of the change from the current Medical Devices Directive 93/42/EU (MDD) to the new Medical Devices Regulation (MDR 2017/745/EU), as well as how current PMCF activities can help your transition to the MDR. You will learn:
- How PMCF study requirements change under the MDR
- PMCF study requirements under the MDD
- The difference between a clinical investigation and a PMCF study
- Important considerations when conducting a PMCF study
We'll discuss all this and more in this 7-page white paper.