A European Medicines Agency (EMA) official provided an update on the agency’s pilot programs aimed delivering scientific advice to manufacturers of high-risk and orphan medical devices to support the clinical development of such products.
Alberto Gañan Jimenez, head of committees and quality assurance department at EMA, provided this update at the RAPS European Clinical, Risk, and Postmarket Surveillance Conference on 23 October.
Article 61(2) of the Medical Device Regulation allows manufacturers of class III and certain class IIb active devices to consult an expert panel for input on the company’s clinical development plans. In 2022, new EU regulations expanded EMA’s mandate to require that the agency provide support to the expert panels on medical devices…
