CEN/TR 17223:2018 Guidance on the relationship between13485 and MDR.. worth the money??

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Yes, it was very helpful!

First, I used it for the update of our regulatory matrix (comparison of different regulatory requirements). And then it is nice to find MDR parts which are not covered by 13485:2016. This way, it took me only a very short time to find out which processes need updates.

Important note: only MDR Article 10 (general obligations of the manufacturer) and Annexes IX and XI are covered by this technical report! All others are not covered!
 
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