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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.


Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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