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In brief

On 9 December 2021, the Medical Device Coordinaion Group (MDCG) published a question and answers document concerning obligations applicable to importers and distributors under Articles 13 and 14 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.


Amongst other things, the document clarifies which activities must be carried out and which requirements must be complied with in order for distributors or importers to be qualified as such, the cases in which a distributor assumes the status of importer, the subjects responsible for indicating the importer on the device, its packaging or accompanying documentation, as well as the cases in which companies providing third party logistics services are considered importers or distributors.

Moreover, the document outlines how importers and distributors must perform verification checks before placing a device on the market, specifying that the relevant responsibilities cannot be delegated. Lastly, the document provides clarification on registration obligations in Eudamed applicable to importers and specifies that although distributors are not subject to said obligations, they could still be subject to national registration requirements of Member States in which they have made the device available.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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