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 . . .
Oh! It looks like you do not have access to this page.
Find the membership plan that suits you, and within a few minutes you are good to go.
Are you a member already? Log in here.