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Product Regulation & Liability

European Union: New provisions on medical devices and in-vitro diagnostic medical devices

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In brief

On 9 July 2024, Regulation (EU) 2024/1860 amending the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) was published in the Official Journal of the European Union.

Key takeaways

In particular, the new Regulation amended the provisions regarding the mandatory use of the European Medical Device Database (EUDAMED) for devices compliant with the MDR and IVDR and for legacy devices, providing for a phased implementation of the modules as they are verified and declared functional.

In addition, the new Regulation introduced a requirement for manufacturers of medical devices, including legacy devices, to notify at least six months in advance of discontinuation or termination if it is reasonably foreseeable that such discontinuation or termination could result in serious harm or risk of serious harm to patients or public health.

With specific regard to the IVDR, the new Regulation extended, under certain conditions, the transitional periods for devices with a certificate or declaration of conformity issued prior to 26 May 2022 under Directive 98/79/EC and placed on the market or put into service after 26 May 2022. This amendment aims at preventing shortages of in-vitro diagnostic medical devices necessary for the proper functioning of health services, while ensuring compliance with current quality and safety requirements.

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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.

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Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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

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