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Content of Declaration of conformity (MDR)

#1
Hi,
I have a question regarding Declaration of Conforming (DoC) according to MDR. As I understand Annex IV of MDR it is not neccessary to state harmonized standards on the DoC, only Common Specifications are required. What is your view on that? Will you include harmonized standards on DoC's made according to MDR or not?

What about writing intended purpose on DoC - as I understand, it is not obligatory to write intended purpose on DoC, because UDI-DI will be included. What is your view on that?

Thank you and best regards.
 

craiglab

Involved In Discussions
#2
Note that you may provide BASIC UDI-DI "aka BUDI-DI" in lieu of "information allowing identification and traceability", not UDI-DI.
The only harmonized standard I plan to include is EN ISO 13485:2016 (I've only included this under MDD).
 
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