The Medical Devices Introductory Course 2020

What PMCF is: MDR (2)

”When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure” Conducted only to achieve the following aims: • confirming safety and performance throughout the expected lifetime of the device • ensuring the continued acceptability of identified risks • detecting emerging risks on the basis of factual evidence

Medical Device Regulation ANNEX XIV, Part B

The Organisation for Professionals in Regulatory Affairs

More definitions

MDR and MEDDEV 2.12/2 rev. 2 Clinical Investigation : Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety or performance of a medical device MEDDEV 2.12/2 rev. 2 PMCF study : A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling MDR Article 74 PMCF investigation : Where a clinical investigation is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), (‘PMCF investigation’)

Medical Device Regulation ANNEX XIV, Part B

The Organisation for Professionals in Regulatory Affairs