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

MDRexpert

Involved In Discussions
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
 
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.
 

Watchcat

Trusted Information Resource
I see this requjirement as one that applies to manufacturing information and starts with the word "complete."
 

yodon

Leader
Super Moderator
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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