The Council of the European Union has published a second set of corrections as part of a corrigendum for the EU’s Medical Devices Regulation (MDR), this time giving manufacturers of certain Class I ...
Dublin, Nov. 03, 2023 (GLOBE NEWSWIRE) -- The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This ...
Under MDR, devices addressing sleep-related conditions—particularly those involving neuromuscular stimulation—are subject to classification, safety assessment, and performance documentation.