How do I get a rough MDD to MDR gap analysis by clauses

V

Vinita

#1
Hello,

how do i get a rough MDD to MDR gap analysis by clauses which will be helpful for us to undergo the transition?
 
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chris1price

Trusted Information Resource
#2
Hi, I haven't seen a published gap analysis. The changes are so significant, It would be difficult to do. I would recommend reading the MDR yourself, it is the best way to understand it.
Chris
 

Jean_B

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#3
Though I agree that MDD to MDR defies a straightforward gap analysis, there is (NPR-) CEN TR 17233:2018. It's a technical report on MDR and IVDR, and which parts are (partly met) by correctly applying EN ISO 13485:2016.

It's the best quickstart i've seen so far, if a company is at the EN ISO 13485:2016 state already.
 
#4
Oops! I think the right reference is 17223:2018 instead of 17233:2018. The first is about MDR and ISO 13485, the other is about water quality, I think!
 

Jean_B

Trusted Information Resource
#6
You are correct. I ran afoul of google's correction algorithm when I verified i had the right link. (And i'm failing to find my edit button :eek: )
 
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