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Product Regulation & Liability

Italy: Medical devices – New Q&As of the European Medicines Agency on the implementation of EU Regulations 2017/745 and 2017/746

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In brief

On 3 May 2024, the European Medicines Agency (EMA) published new Q&As for applicants, marketing authorization holders of medicinal products, and notified bodies on the implementation of the EU Regulations on medical devices and in vitro diagnostic medical devices (i.e., EU Regulations 2017/745 and 2017/746).

Key takeaways 

The new Q&As are based on the experience gained from the application of the regulations and the specific cases encountered so far, and aim at providing practical considerations on the relevant implementation, with particular reference to those products that consist of a combination of medicinal products with medical devices.

In particular, the Q&A contains regulatory and procedural guidance in relation to (i) medical devices that form an integral product with a medicinal product and their life-cycle management, (ii) medicinal product that include a medical device in their packaging and the relevant modalities to label them, (iii) the consultation procedure for ancillary medicinal substances that are integral part of medical devices, and (iv) the consultation procedure for companion diagnostics.

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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.

Author

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

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