Harmonised Standards (EN ISO 13485 / EN ISO 14971) in MDR (2017/745/EU)

qu1nn

Involved In Discussions
#1
Hello,


MDD used to have a consistent and detailed harmonized standards listing, this listing included EN ISO 13485 and EN ISO 14971.

Currently for the MDR (2017/745/EU) Medical devices
there is a harmonized list, but it is very short and does not include what I am looking for...

Where do I find what version of EN ISO13485 and EN ISO14971 are considered Harmonized?

Thank you for your time
Quinn
 
Elsmar Forum Sponsor

Philip B

Quite Involved in Discussions
#4
EN ISO 13485:2016 + A11:2021 has an informative Annex ZA showing the relationship between the standard and the MDR. Not harmonised yet of course but is a good indication of where things are going.
 
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