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MDD to MDR - Technical File conversion

dr1vn

Involved In Discussions
#1
I already have a Technical File for the MDD. But to comply with the new EU MDR, I will need to convert the documents to follow the updated requirements. The data and records are all there thanks to the gap analysis we did earlier, but I would like to know how everyone is handling conversion of documents?
 

Jnks_Meddev

Involved In Discussions
#3
Hello,

I am currently writing SOP for MDR technical file. Can someone please share scrubbed version.
Thanks in advance and really appreciate your help!
 

s27bax

Starting to get Involved
#4
I would find that really useful also if someone could share their interpretation of what the structure of their MDR tech file is like.
The MDR annex II and III do essentially form the structure, however, if anyone could share a more detailed structure than An II and III headings, that would be really useful. When I am a bit further into it, I would be happy to share my interpretation also.
 
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