The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made public.
The IVD Expert Panel, set up in the context of the EU’s IVD Regulation, has issued its first opinion based on a manufacturer performance evaluation report submitted by a notified body.
The seven-page document has been published on the website of expert panels on medical devices and in vitro diagnostics (Expamed) and is a review of a hepatitis E virus (HEV) test.
The advice is provided in the context of the performance evaluation consultation procedure (PECP), which is an additional element of conformity assessment by notified bodies for specific high-risk in vitro diagnostic devices (IVDR Article 48.6).
