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

On 12 February 2024, the Medical Device Coordination Group (MDCG) issued a new guidance document, MDCG 2024-2.

The European Medical Device Nomenclature (EMDN) is required to be updated yearly based on the practical use of the EMDN and feedback from its users. This MDCG document describes the processes that will be used to make these annual updates. As well as the annual updates, the MDCG document also explains the process for any ad-hoc updates to the EMDN.

There are three defined groups involved in this process:

1. MDCG Nomenclature Working Group – This expert group provides assistance and advice to the MDCG on all implementation issues related to the EMDN. The working group is composed of representatives of Member States’ Competent Authorities.
2. EMDN Technical Team (EMDN-TT) – This is a smaller technical group under the MDCG working group. This team is composed of Italian Experts (the EMDN system is based on the original Italian system) who assess new and revised codes of the EMDN for consideration by the MDCG Working Group.
3. Users – Users of the EMDN include but are not limited to Competent Authorities, Notified Bodies (NB), manufacturers, EU Authorised Representatives, importers, distributors, Systems & Procedure Pack producers, trade associations, professional bodies, healthcare professionals, hospitals, laboratories, patients, consumers and the World Health Organization (WHO).

Procedure for Annual Revision of EMDN

The annual revision will consist of four phases:

• Phase 1: Collection of Request (January) – Consists of user requests through the “Platform for EMDN Requests“. The platform is open throughout the year, but the deadline for submitting requests is 31st January 20XX for processing in that same calendar year.
• Phase 2: Evaluation of the requests and analysis of the practical use (February – July) – This phase involves a technical evaluation by the EMDN-TT of the following:
  • Requests submitted during Phase I
  • Requests by the MDCG Working Group
  • EMDN usage in EUDAMED (e.g., review of devices registered with multiple codes, review of devices registered with the code extension “99”)

Following the technical evaluation, a first draft proposal for the update of the EMDN is prepared. This proposal and the list of rejected requests are submitted to the MDCG Working Group for review.

• Phase 3: Validation and Endorsement (August – October) – The MDCG Working Group reviews all information from Phase 2 and gives feedback to the EMDN-TT. Following final comments by the EMDN-TT, the MDCG Working Group confirms a draft version of the EMDN.
• Phase 4: MDCG endorsement and publication (November – December) – This stage involves the endorsement of the final draft by the MDCG and publication of the officially endorsed update in EUDAMED and the EMDN browser.

Process for Ad-Hoc Updates of the EMDN that Require an Expedited Review

Only requests submitted by Competent Authorities and Notified Bodies qualify under the ad-hoc procedure.

Under the ad-hoc update procedure, only new code requests may be submitted. If the new code request results in the need to render obsolete or split other codes, the request will be redirected to the annual procedure process.

The applicant of the new EMDN code will complete a form with relevant information and submit this to the EU Commission. The Commission will then pass the request to the EMDN-TT. The EMDN-TT will review the request and provide feedback to the Commission, who will inform the applicant whether the application is eligible for the ad-hoc procedure.

If the request is considered ineligible, the user will be informed, and their submission will be deferred for an assessment under the annual update procedure.

If the request is considered eligible for the ad-hoc procedure, the EMDN-TT will send a technical proposal to the MDCG Working Group for review and endorsement, and the new EMDN is added. During the annual review procedure, ad-hoc updates will be reflected in the annual updated version of EMDN.

NAMSA Expert Weighs In

The changes above have minor impacts on manufacturers, if the manufacturer has a novel device which presently has no relevant EMDN number. The Phase 1 process gives a mechanism for obtaining a new EMDN number. EMDN numbers are primarily used for defining the surveillance reviews of Class IIb technical documentation via the sampling process, making it mainly of interest to Notified Bodies.

Most of the guidance relates to actions via the EU Commission and Regulatory Authorities and is only of interest to manufacturers to understand how the allocation of new EMDN numbers is managed, unless the manufacturer presently has issues with the EMDN process.