Update – MDCG 2022-9 rev.1 – Summary of safety and performance template

Yesterday, revision 1 of the MDCG guidance 2022-9 was published. It provides clarification regarding Summary of Safety and Performance template, especially when devices are intended to be used by lay persons only.

Please make sure, that you clearly distinct the user groups in your intended purpose definition and also keep in mind: The Summary of Safety and Performance template does not replace any requirement for an Instruction of Use.

More details on Update – MDCG 2022-9 rev.1 – Summary of safety and performance template – April 2024 – European Commission (europa.eu)