MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature

  1. Annual Revision Process: The European Medical Device Nomenclature (EMDN) undergoes an annual review and update process, involving four distinct phases: Collection of requests, Evaluation and analysis, Validation and endorsement, and MDCG endorsement and publication.
  2. Actors Involved: The key actors in managing and maintaining the EMDN include the Nomenclature working group (NOM WG), European Medical Device Nomenclature Technical Team (EMDN-TT), and various users such as competent authorities, notified bodies, manufacturers, healthcare professionals, and more.
  3. Ad-hoc Update Procedure: While the general rule is an annual update, a pilot procedure allows for ad-hoc updates in cases of established need, with only competent authorities and notified bodies qualifying for this expedited process. The ad-hoc update requires detailed information and goes through a consultation, review, and endorsement process by relevant bodies

See more details here.