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

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#3
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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#4
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!

Would you be willing to share your matrix?
 
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