Annual EMDN Code Revision: Monitor for Published Changes

EMDN codes are subject to change. Each year, the Commission publishes a list of all codes that have been newly created, revised, merged, or obsoleted.

There is no mechanism to individually notify impacted users of the changes. Therefore, manufacturers must monitor for the annual publication of EMDN code updates to assess if their devices were impacted. It is the manufacturer’s responsibility to ensure their documentation (and EUDAMED registration) is updated “in a timely manner and reasonable manner, and at the latest prior to the next annual surveillance audit following the finalisation of the annual EMDN update cycle.”

The update will be published on the Commission’s MDCG guidance page. Casus will also announce it on its Regulatory Updates page.