Spotlight on similar devices under the Medical Device Regulation

This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market clinical follow-up evaluation (PMCF) docu ments, based on the Regulation (EU) 2017/745 (referred to as the medical device regulation [MDR] in this article) and relevant Medical Device Coordination Group (MDCG) documents. Beginning with the concept of similar devices, the article presents how to identify similar devices, use similar device data, and apply this knowledge to clinical documentations. A stepwise approach provided at the end of the article aims to assist manufacturers and medical writers in this process.

Contributors: Payal Bhatia (author and section editor)

Medical Writing. 2023;32(2):92–94. https://doi.org/10.56012/dlip9626