Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device

Awadine

Involved In Discussions
Hi

i have heard that some Notified Bodies are requiring manufacturers of devices currently leveraging MDD certificates, as permitted under MDR transitional provisions, to explicitly declare conformity with applicable provisions of MDR on their MDD declarations of conformity.

Has anyone else experienced this?

Declaring compliance with MDD and Article 120(3) of MDR just seems a bit strange to me.
 

Rincewind

Involved In Discussions
Hello,

yes we are doing this for DoCs which are issued under MDD. Our Notified Body did not ask us to do it but our legal council recommended it.

We added to the MDD DoCs a reference to Art. 120 (3).
 
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