Regarding the GSPR: is a Procedure for identification of the General safety and performance requirements needed?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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.
For more information, see:
- EU MDR Article 10 - General obligations of manufacturers https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/
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Jan 10, 2023