1st revision of the MDCG 2022-9 guidance on the template for the Summary of Safety and Performance characteristics under Regulation (EU) 2017/746

Published by the Medical Device Coordination Group (MDCG), the MDCG 2022-9 guidance proposes a template to follow the Summary of Safety and Performance (SSP) under Regulation (EU) 2017/746. This summary must be validated by a notified body and made available to users through the European database on medical devices, EUDAMED.

This first revision brings, among other things, clarifications regarding the availability of the SSP for patients, as well as an optimization of the terminology used and its structure.

DOWNLOAD THE GUIDANCE MDCG 2022-9 Rev.1