BRUSSELS – The European Commission’s proposed revisions to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) include specific changes to the regulation of medical device ...
The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are ...
Under MDR, devices addressing sleep-related conditions—particularly those involving neuromuscular stimulation—are subject to classification, safety assessment, and performance documentation.
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