MDCG Q&A on EUDAMED Actor registration for importers (update)

The MDCG has released a revised version of Questions & Answers document clarifying actor registration obligations in accordance with MDR Article 31 and IVDR Article 28.

Newly added section is particularly relevant for importers. Question number 9 is displayed below:
Do importers who carry out the activities mentioned in Article 16 MDR/IVDR also need to register as manufacturers in EUDAMED?
On one hand, importers who assume the obligations incumbent on manufacturers according to Article 16 . . .

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