The Medical Devices Introductory Course 2020

POST-MARKET CLINICAL FOLLOW- UP (PMCF)

The Organisation for Professionals in Regulatory Affairs

What PMCF is: MDR (1)

• Medical Device Regulation ANNEX XIV, Part B • Section dedicated to PMCF (with Part A dedicated to clinical evaluation) • A continuous process • Shall be addressed in the manufacturer's post-market surveillance plan • The CER should describe residual risks and uncertainties or unanswered questions that should be further evaluated during PMS and the plan to conduct PMCF

The Organisation for Professionals in Regulatory Affairs