ISO 13485 & EU MDR / GSPR
Regarding the GSPR: is a Procedure for identification of the General safety and performance requirements needed?
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According to the MDR Article 10, point 9, The quality management system shall address at least the following aspects:
b) identification of applicable general safety and performance requirements and exploration of options to address those requirements;
So there is no direct requirement for the procedure, but as part of your QMS, there must be an explanation for the general safety and performance requirements.
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