MDR GSPR Checklist wanted

#1
Does anyone have or will be willing to share a checklist document that includes the list of GSPR according to the MDR and a list of all the possible harmonised standards, common specifications or other documents that would apply and if possible the methods used to demonstrate conformity with each applicable GSPR.

It could be somethid like this. What matters is the list of all standards and solutions that apply for each general requirement

Thanks
GSPR  CHECKLIST EXAMPLE.jpg
GSPR CHECKLIST EXAMPLE 1.png
 
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Rincewind

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#2
The columns for "Standards & Solutions" and "Evidence" in your example are extremely individual depending on your product and the structure of your tech file.

While there are standards and Guidelines which apply to all products there are a lot more which are product specific.

A checklist including all possible standards seems to me nearly unmanageable.
 
#3
Thanks for your reply. I realized once starting the process that is more product specific, so now i am workng on it

Btw do you know which ones of this mdr gspr the manufacturer should comply with in a CER. There is no specific guidance document issued by the MDCG yet so it can be a little bit tricky to figure out which ones are applicable for a CER.

THANKS
 

Raisin picker

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#4
Btw do you know which ones of this mdr gspr the manufacturer should comply with in a CER. There is no specific guidance document issued by the MDCG yet so it can be a little bit tricky to figure out which ones are applicable for a CER.
I was wondering the same. I'm currently with GSPR 1, 2 and 8.
Article 61 of the MDR says "conformity with relevant general safety and performance requirements" and Annex XIV (1a) asks to provide "an identification of the general safety and performance requirements that require support from relevant clinical data".
To me, that sounds as if you have to define your relevant GSPRs for every device new.
 
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