EMA scientific advice for medical devices
European Medicines Agency has recently announced a pilot to provide scientific advice to manufacturers of certain high-risk medical devices.
Article 61(2) of Medical Device Regulation states, that the expert panels may give scientific advice to manufacturers of some high-risk medical devices on their intended clinical development strategies and proposals for clinical investigations.
This advice is applicable for class III medical devices and class IIb active medical devices intended to administer or remove medicinal products from the body.
Starting at the end of February, EMA will be accepting letters of interest from companies that would like to be considered for the pilot.
Europe is encouraging the manufacturers to early communication with the EU and national competent authorities with respect to development of their products through various types of communication, including scientific advice procedure. This may help manufacturers to find the most efficient way to achieve their goal. Implementing the requirements of MDR, EMA provides new possibilities for medical device manufacturers as well.
As announced, as a part of the pilot project, 10 medical devices will be selected for scientific advice by the EMA’s expert panels.
Would you like to try to be one of the first manufacturers, getting this kind of scientific advice for your medical device? STARoDuB team may facilitate you with this. Please don’t hesitate to contact us!