High Level Approach for PMCF Activities

The Medical Devices field is a constantly moving area. Several devices are invented or improved every day to benefit patients. The new Regulation (EU) 2017/745, which is more demanding for the manufacturers, aims to improve device safety while supporting innovation on the European Market. Post Market Surveillance (PMS) and Post-market Clinical Follow-up (PMCF) whose plan is an integral part of the PMS plan.

This Whitepaper discusses about:

• PMS Plan System
• Scope of PMCF
• The aim of the PMCF plan
• Objective of PMCF
• PMCF Activities
• Design considerations for PMCF under the MDR