The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG 2024-02, on the procedures for the updates of the European Medical Device Nomenclature (EMDN). This guidance explains how the nomenclature will be annually reviewed and updated based on the EMDN use and related users’ feedback.
Procedure for the annual revision of the EMDN
The annual revision of the EMDN codes foresees four phases. In the first phase, the platform for EMDN requests collects user feedback. In the second phase, the EMDN-TT (European Medical Device Nomenclature Technical Team) evaluates the requests and analysis. Afterward, a first draft proposal for the update of the EMDN follows, submitted to the Nomenclature Working Group (NOM WG). The NOM WG evaluates the draft and endorses a final draft in the third phase. In the fourth and last stage, the MDCG endorses the final draft.
Pilot procedure for the ad-hoc updates of the EMDN requiring an expedited review
Ad-hoc procedures are procedures for requests for new codes submitted by competent authorities and notified bodies. The EMDN-TT will evaluate the request that the Commission receives and following their assessment, the Commission informs the applicant about the outcome. If accepted, the EMDN-TT further analyses the request and issues a technical proposal to share with the NOM-WG for review and endorsement.
Under the MDR and IVDR, EMDN codes are mandatory for manufacturers. Contact us if you want to know how to assign EMDN codes to your devices.
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