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(1) MDR/IVDR, as clarified in MDCG 2018–6, have the obligation to register as Manufacturers in EUDAMED.
On the other hand, importers who carry out the activities mentioned in Article 16(2) MDR/IVDR do not have any obligation to register as manufacturers in EUDAMED since these activities are not considered a modification of a device that could affect its compliance with the applicable requirements, so they do not act as a manufacturer.
In any case, importers are subject to the obligation of registering as Importers in EUDAMED in accordance with Article 31 MDR and 28 IVDR. This registration is due to the fact that the importer places the devices on the EU market, and is not due to the fact that he carries out the activities mentioned in Article 16 (2) MDR/IVDR (namely, relabelling or repackaging of devices). (MDCG, 2021).
Do not forget to follow us on LinkedIn!