Last February 2024, the Medical Device Coordination Group (MDCG) updated the MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature regarding the update of the European Medical Device Nomenclature (EMDN).

As described in the guideline, the European nomenclature for Medical Devices and IVDs, governed by Article 26 of the MDR Regulation (EU) 2017/745 and Article 23 of the IVDR Regulation (EU) 2017/746, is annually reviewed and updated on the basis of its practical use and feedback received from users.

The devices Nomenclature Working Group (NOM WG) provides assistance and advice to the MDCG on all implementation, update and maintenance issues related to the EMDN, with the aim of supporting the operation of the future European Database on Medical Devices (EUDAMED). This group is in turn supported by the European Medical Device Nomenclature Technical Team (EMDN-TT), which is in charge of evaluating and reviewing proposals or providing draft amendments including the definition of new codes and revisions of existing ones.

The annual reviews are divided into four phases. In the first phase, which ends in January, the collection of applications takes place. In the second phase, between February and July, there is the evaluation of applications and the analysis of their practical use. In the third phase, between August and October, there is the validation and approval of the applications and finally, in the fourth and final phase, between November and December, there is the approval and publication of the MDCG.

As mentioned above, the general rule is that all requests must follow an annual procedure; however, requests submitted by competent authorities and Notified Bodies with dedicated forms may benefit from ad hoc procedures. Regarding the latter, only requests for new codes may be submitted, and if the request for a new code entails the need to make other codes obsolete or split, then the request will be redirected to the annual procedure route.

The introduction of more and more technologically advanced devices prompts regulators to provide guides that can help manufacturers to produce safe and high-performance devices to safeguard the health of users and patients.


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