Miriam Di Fonzo -

EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for all class III medical devices and class IIb active devices intended to administer and/or remove medicinal product(s). Manufacturers can submit their letter of interest to be part of the pilot on scientific advice which will be provided by the medical device expert panels.

The pilot will prioritise certain types of medical devices:

  • 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 paediatric use;
  • devices addressing medical conditions that are life threatening or cause permanent impairment of a body function and for which current medical alternatives are insufficient or carry significant risks;
  • novel devices with a possible major clinical or health impact.

The expert panels will provide free advice to ten selected applicants on their clinical development strategy and/or proposals for clinical investigation. The pilot will last approximately one year and will help to establish an efficient scientific advice procedure.

More information on the process and the selection criteria is available on EMA’s website.

The first five applications will be selected in April. Small and medium-sized enterprises are strongly encouraged to submit their letters of interest.

Regulatory Pharma Net (RPN) is available to support in the procedure and to assist on all regulatory needs.

Feel free to contact us at info@regulatorypharmanet.com

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