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MDR harmonized standards

mf389

Starting to get Involved
#1
BSI lists the newer version of 14971 as "EN ISO 14971:2019", Does this mean it is harmonized in the EU? Is this to the MDD or the MDR? Are they going to release a list of harmonized standards for the MDR as they currently have for the MDD?



Thoughts?
 
Elsmar Forum Sponsor
#4
Greenlight Guru recently had a webinar on ISO 14971 and MDR (by Peter Sebelius).

I cannot post links (yet) but if you google iso 14971 mdr this webinar should show up.

I was rather chocked when I listened to this webinar. It turns out that the attempt they did to harmonize ISO 14971:2019 with the MDR failed!!

Peter said in the webinar that there will be a meeting this spring, and hopefully a sensible/pragmatic solution can be found.

If this is news to you, and if you develop medical devices for the EU market, I strongly recommend listening in to Peter's excellent presentation on ISO 14971 and MDR.

Until more information is available, my preliminary conclusion is that we will keep adhere to ISO 14971:2019, and hope for the best, after all it is "state of the art". Hopefully this will be sorted out.

What do other people think about this?
 
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