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.
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