The Medical Devices Introductory Course 2020

Clinical Evaluation

• For all classes of device, conclusions of the PMCF evaluation report shall be taken into account for clinical evaluation • PMCF evaluation report should be part of the CER and technical documentation • For implantable devices and for class III devices, other than custom-made or investigational devices, relevant information on PMCF should be included in the publicly- available SSCP

The Organisation for Professionals in Regulatory Affairs

Post-market surveillance

• For Class I devices, a summary of results and conclusions of PMS data analyses should be included in the post-market surveillance report (PMSR) • For Class IIa, IIb and III devices main findings of PMCF to be included in the Periodic Safety Update Report (PSUR)

The Organisation for Professionals in Regulatory Affairs