Món Clínic acts as a consultant in the EMA pilot for Scientific Advice for Medical Devices
Món Clínic acts as a consultant in the EMA pilot for Scientific Advice for Medical Devices
Món Clínic is taking part in Scientific Advices provided by the experts panel in the pilot test opened by the EMA (European Medicines Agency) to manufacturers of certain high-risk medical devices, with the aim of guiding and helping them on their intended clinical development strategies and proposals for clinical investigations.
Up to now, the pilot has prioritized the following 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
As a consultant, Món Clínic is providing guidance to applicants on their clinical development strategy and/or proposals for clinical investigation as well as to the questions and manufacturer’s position to request the opinion of the Expert Panel. The pilot has already been closed and is expected to establish an efficient scientific advice procedure to foster innovation and promoting faster patient access to safer and more effective devices.
More info:
https://www.ema.europa.eu/en/news/ema-pilots-scientific-advice-certain-high-risk-medical-devices
