Connection between Technical File and Declaration of Conformity

JeantheBigone

Quite Involved in Discussions
Is there a requirement that every update to a Technical File requires a new Declaration of Conformity? I say no, because a Technical File may need to be updated when a Procedure is added, replaced or obsoleted. A Declaration of Conformity declares conformity to directives and standards, so if those change then a new DoC would need to be created..
 

Rincewind

Involved In Discussions
I agree, you are declaring conformity to different standards or specifications and not to a specific Version of your technical documentation.
In my opinion a new DoC is needed if the points mentioned in the MDR (Annex IV) change or if there is a period of validity defined.
 

CharlieUK

Quite Involved in Discussions
Agreed - the DoC only needs to be updated when something on it needs to be changed (for example model number, batch numbers (if used), applied standard etc.)
 
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