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In brief

On 20 March 2023, Regulation EU 2023/607 (“Regulation“) was published in the Official Journal of the European Union, amending the transitional provisions of Regulations EU 2017/745 on medical devices (“MDR“) and 2017/746 on in vitro diagnostic medical devices (“IVDR“).

Key Takeaways

In particular, as regards the MDR, the Regulation provides, among other things, for the extension of the deadlines for placing on the market or putting into service devices with certificates issued by notified bodies in accordance with the previous legislation. Specifically, said devices may be placed on the market, under the conditions set out in the same Regulation, until 31 December 2027 or 31 December 2028 depending on the respective risk class. In addition, the Regulation repealed the so-called “sell-off” period, that is the deadline for the disposal of both medical devices and in vitro diagnostic devices lawfully placed on the market prior to the entry into force of the MDR and IVDR and during the transitional period.


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.


Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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