Regulatory Affairs Professionals Society

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 ...
RAPS

FDA Finalizes Guidance on Device Classification Procedures

The US Food and Drug Administration (FDA) has released a new guidance document finalizing its recommendations for the medical device industry on how to use Classification Product Codes (CPC), a ...
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 ...