The Medical Devices Introductory Course 2020

What is clinical evaluation? MEDDEV 2.7/1 rev. 4

Methodologically sound, ongoing process to: • Collect, appraise and analyse clinical data pertaining to a medical device • Analyse whether there is sufficient clinical evidence to confirm compliance with relevant [GSPRs] for safety and performance when using the device according to the manufacturer’s instructions for use • Produce a CER which will constitutes part of the clinical evidence for conformity assessment and is part of the technical file

The Organisation for Professionals in Regulatory Affairs

Clinical data MDR definition

Information concerning safety or performance that is generated from the use of a device and is sourced from the following: • Clinical investigation(s) on the device concerned or an equivalent device • Reports published in peer-reviewed scientific literature on other clinical experience of the device concerned or an equivalent device • Clinically relevant information from Post-Market Surveillance (PMS), in particular PMCF

The Organisation for Professionals in Regulatory Affairs