Italy: EMA: pilot project on scientific advice for certain high-risk medical devices

In brief

On 27 February 2023, the EMA announced the launch of a pilot project for the benefit of small and medium-sized enterprises aimed at providing scientific advice on clinical development strategy and clinical investigation proposals for class III medical devices and class IIb active devices intended to administer or remove medicines.

The project, which will last approximately one year and is meant to contribute to the development of an efficient scientific advisory procedure, will involve panels of medical device experts to advise ten selected applicants free of charge on their clinical development strategies and clinical investigation proposals.

In the selection of candidates, priority will be given to the following types of devices: (i) devices that benefit a small group of patients in the treatment or diagnosis of a disease or condition, such as devices intended for the treatment of a rare condition, known as “orphan devices,” and devices for pediatric use; (ii) devices that treat life-threatening medical conditions or cause permanent impairment of a bodily function and for which current medical alternatives are insufficient or carry significant risks; and (iii) new devices with possible major clinical or health impacts.

Companies can submit their applications for participating in the project until the end of August 2023.

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