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MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature
MDCG 2024-2 establishes how the European Medical Device Nomenclature is updated each year. A summary of the four-phase process and the pilot ad-hoc procedure now available to authorities.
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.
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.
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.
KEY TAKEAWAY
How the European Medical Device Nomenclature Is Updated
MDCG 2024-2 establishes that the European Medical Device Nomenclature (EMDN) is updated annually through a four-phase process covering collection of requests, evaluation and analysis, validation and endorsement, and MDCG endorsement and publication. The Nomenclature working group and the EMDN Technical Team manage the process, working with competent authorities, notified bodies, manufacturers, and healthcare professionals. A pilot ad-hoc update procedure is available in cases of established need, but only competent authorities and notified bodies qualify for this expedited route.
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