EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation.
Manufacturers of class III devices and class IIb active devices intended to administer or remove medicines can now submit their request for advice via a portal and consult the medical device expert panels at different stages of the clinical development.
Advice given by the medical device expert panels is a key tool to foster innovation and promote faster patient access to safer and more effective devices…
