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EU MDR - Annex II 3b - What documents fall under this requirement?

MDRexpert

Involved In Discussions
#1
Hi Everyone,

Can someone explain me EU MDR Annex II 3b requirement. What documents fall under this requirement?
To give you an example - We are currently a contract manufacturer for a X company. Under this new regulation our X company requires all the major as well as minor updates notified to them. Can someone explain/share how they see this requirement?

Regards,
Akanksha
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
Either the technical documentation lives at both sites or just the Company X site. If it is only at the Company X site, then they need to always have the latest documentation in their technical file. This means you will have to share every revision with them.
 

yodon

Staff member
Super Moderator
#4
To address your first question (what documents), I think this would include assembly work instructions, material specifications, in-process and final test procedures, etc.
 
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