Do you need an Applicable general safety and performance requirements Checklist?

MakingADifference

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#1
Hi All.

Please could someone provide some clarification regarding the applicable general safety and performance requirements? The MDR is new to myself, like it is for all of you so I never had the please of of getting to know the MDD which may have helped as I believe this is renamed from the Essential Requirements Checklist?

How do I demonstrate compliance for this? Is this a checklist / type of gap analysis against the MDR?

Thanks in advance
 
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shimonv

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#2
I recommend reading BSI guidance document on General Safety and Performance Requirements.
In a nutshell, you will need to create a table showing how you fulfil each of these requirements through stating the applicable standers in once column and specifying the evidence of compliance in another column (test report, IFU, etc.).

Shimon
 
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