Medical Writing EU Regulations New documents required by the medical device regulation

Volume 29, Issue 3 - EU Regulations

New documents required by the medical device regulation

Abstract

This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical performance. The clinical evaluation plan describes the process that will be used to evaluate the performance and safety of a medical device, eventually resulting in a clinical evaluation report. The PMCF plan describes the procedures to collect post-market clinical data that are presented in the PMCF evaluation report. Finally, the summary of safety and clinical performance presents the relevant clinical evidence related to a medical device to healthcare professionals and patients.

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