EU Declaration of Conformity for Class I

JP12345

Involved In Discussions
Hi,

The MDR states that the EU DoC must contain (ref Annex IV (8)) that 'where applicable.... a description of the conformity assessment procedure performed'

In the case of class I medical devices, does anybody know how to state which conformity assessment route is used, which part of the MDR should be referenced? or if you do not need to mention conformity assessment route as they are class I?

The class I devices we manufacture are simple class I, not sterile etc

Thank you for any help!
 

KShaw

Involved In Discussions
Hi!

For a simple class I, I would usually go with "Issuing the Declaration of Conformity in accordance with Article 19 after drawing up the technical documentation laid out in Annexes II and III of the EU MDR". You can find this in Article 52 of the MDR.

Best wishes,
Kenneth
 
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