The Medical Devices Introductory Course 2020

Types of PMCF study

• No hard and fast rule when it comes to determining the most appropriate methodology for a PMCF study • Reasons for PMCF will determine how and what should be studied, duration and endpoints • Typical examples include: • The extended follow-up of patients enrolled in pre-market investigations • A new clinical investigation with endpoints relating to specific residual risks in a particular patient population • A manufacturer-sponsored device registry • Retrospective analysis of patients previously exposed to the device

The Organisation for Professionals in Regulatory Affairs

Generating a PMCF plan: MDR

ANNEX XIV. PART B (6) – PMCF plan is required • There are minimum requirements for what is to be included with a PMCF plan – much of it overlaps with MEDDEV 2.12/2 BUT… • …MDR has broadened the scope of PMCF planning from that in the MEDDEV guidelines which focus on the PMCF

study/investigation to include: • Gathering of experience gained • User feedback

• Screening of scientific literature • ‘other’ sources of clinical data • See also MDCG 2020-7 – PMCF plan template

The Organisation for Professionals in Regulatory Affairs