Post-Market Clinical Follow-up (PMCF) studies under the EU MDR

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.