RAPS

New MDCG guidance shows how devices fit into MDR’s classification rules

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 ...
RAPS

MDCG updates guidance on device classification, EMDN, and supply disruptions

The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the classification of products under the Medical Device Regulation (MDR) and the In Vitro ...
JD Supra

Call for comments: FDA wants feedback on the distinct classification of existing device accessories into Class I

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...
China Briefing

China Clarifies Medical Device Classification for Brain-Computer Interfaces: A Guide for Foreign Investors

China just clarified its classification for brain-computer interfaces — and that’s a big deal for anyone eyeing this market. NMPA’s new guideline sorts BCI devices into concrete risk classes and ...