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In brief

Pending the full functionality of the European Database on Medical Devices (“Eudamed“), the European Commission made available two new modules, to be used on a voluntary basis, for the registration of medical devices by economic operators and for the registration of certificates of conformity by notified bodies. 


In particular, the first module allows manufacturers to enter information on the devices they place on the EU market into Eudamed, allowing easier traceability of the same devices, while the second one allows notified bodies to register certificates of conformity and the summary of safety and clinical performance if all the parties referenced in the certificates are already registered.

These modules are in addition to the actor registration module, made available on 1 December 2020, which allows economic operators to submit, by means of an actor registration request, the information necessary to obtain an actor identifier/single registration number.

Moreover, on 26 November 2021, the European Commission published Implementing Regulation (EU) 2021/2078 (“Regulation“) setting forth detailed rules for the establishment and management of Eudamed. Said Regulation, which will enter into force on 19 December 2021, provides information, among other things, on the methods of access, registration, processing of personal data, measures adopted by the Commission in case of malfunction and IT security matters.

Author

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

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.

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