The Medical Devices Introductory Course 2020

HOW ARE THE OUTCOMES OF PMCF USED?

The Organisation for Professionals in Regulatory Affairs

Documenting the findings of PMCF

MDR Annex XIV • The manufacturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation report • For class III devices and implantable devices, PMCF evaluation report shall be updated at least annually PMCF guidelines (MEDDEV 2.12/2) • “The PMCF study should. . .have a final report with conclusions relating back to original objective(s) and hypothesis” • Template for PMCF evaluation report provided in MDCG 2020-8 (published April 2020)

The Organisation for Professionals in Regulatory Affairs