21 Notified Bodies Declare Intention To Stay In EU Game
Almost two dozen notified bodies say they will test against the new European Union Medical Devices Regulation, and 11 against the new IVD Regulation. Some certainty at last, but many questions remain.
You may also be interested in...
TEAM-NB needs to redirect resources from notified body oversight toward helping its 22 members fall into line with requirements under the forthcoming Medical Devices Regulation and IVD Regulation. So what does this mean for TEAM-NB non-members and future notified body numbers?
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.