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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 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.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.