Posted by Michael Wonder on 27 Feb 2023
EMA pilots scientific advice for certain high risk medical devices
27 February 2023 - The EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)).
As of today, 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.
