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In brief

With judgment No. 1776 of 2 March 2021, the Council of State ruled that, for the purposes of participating in a public tender for the supply of medical devices to the NHS, the manufacturer based in another EU Member State is not required to register its product in the National Database of Medical Devices and specified that national provisions cannot restrict the free movement of devices already regularly placed on the EU market with the prescribed CE marking.


In this regard, the administrative judge also clarified that the procedure for the registration in the National database applicable to manufacturers established in another EU Member State, rather than representing a prerequisite for the participation in public tender procedures, is a mere option available to those manufacturers intending to make NHS entities aware of the technical characteristics of their products, thus avoiding any requests for information on technical data within the tender procedure.

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.