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Update – MDCG 2022-9 rev.1 – Summary of safety and performance template
MDCG has published revision 1 of guidance 2022-9 on the Summary of Safety and Performance template. A summary of the clarifications, particularly for lay-user devices.
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
KEY TAKEAWAY
Clarifying the Summary of Safety and Performance Template
MDCG has published revision 1 of guidance 2022-9, clarifying the Summary of Safety and Performance template, particularly for devices intended to be used by lay persons only. Manufacturers should clearly distinguish user groups in the intended purpose definition and remember that the SSP template does not replace any requirement for an Instruction for Use.
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