Risk based approach to Post-Market Clinical Follow-up (PMCF)

MedTech Europe wishes to highlight its concerns regarding the interpretation of the Medical Devices Regulation (EU) 2017/745 (MDR) PMCF requirements for low-risk devices with a demonstrated safety profile, and the resulting impacts on healthcare professionals (HCPs), patients and manufacturers.

Manufacturers have observed a significant tendency towards expectations from Notified Bodies and Competent Authorities for Post-Market Clinical Follow-up (PMCF) clinical investigations almost by default for all devices, rather than PMCF activities that are proportionate to the intended purpose, characteristics and risk-benefit of the device. A more pragmatic approach is needed to ensure that PMCF clinical investigations are conducted only when appropriate, thereby alleviating the impact on healthcare professionals and patients.

Please consult our full paper to learn more.