Background

Industry may submit requests to amend or add new EMDN codes, as needed. For an overview of the process and timing to do so, please read: How do I request a new EMDN code?

Outcome of 2024 EMDN Requests

The results are outlined in MDCG 2025-2 (Summary of EMDN 2024 Submissions and Outcome of Annual Revision): HERE

The possible outcomes are 1) Accepted, 2) Partially Accepted, or 3) Not Accepted. The document provides a brief rationale for the Technical Team’s decision for each request.

Examples of new EMDN codes include:

• L0612 Urology Prosthetic Instruments and Kit, Reusable
• W0105060404 Candida Auris – NA Reagents

Excel List of All 2024 Revisions

MDCG 2025-3 (EMDN Version History (2024)) is available: HERE

This outlines all the codes newly created, amended, split, or obsoleted.

There is no mechanism to individually notify impacted users of the changes. Therefore, manufacturers must review MDCG 2025-3 to verify if the new/amended/obsoleted codes impact their devices.

On an ongoing basis, manufacturers should have a process to review the annual list of EMDN revisions. It is the manufacturer’s responsibility to ensure their documentation (and EUDAMED registration) is updated “in a timely manner and reasonable manner, and at the latest prior to the next annual surveillance audit following the finalisation of the annual EMDN update cycle.”

The EMDN code changes are already reflected in the EMDN database (see example below). Further, Casus will maintain the annual EMDN Version Histories in our: List of EU, UK, and Swiss Regulations & Guidance Documents

Procedure on Updating EMDNs Revised

MDCG 2024-2 rev.1 (Procedure for updates to EMDN) is available: HERE

There was a minor update to convert the numbered list of required information into a table format. This is to align the guidance with the newly published form (MDCG 2025-1), which is used to make ad hoc EMDN code requests.

Note that the ad hoc request process is 1) only available to Competent Authorities and Notified Bodies, and 2) only to request a new code be added. All other EMDN requests must be made through the standard annual procedure pathway.

EMDN Ad Hoc Request Form

MDCG 2025-1 (EMDN Ad Hoc Procedure Form) is available: HERE

As noted above, this process is currently only available to Competent Authorities and Notified Bodies. All other EMDN code requests must be made through the standard annual procedure pathway.

EMDN FAQs Revised

MDCG 2021-12 rev.1 (FAQ on EMDN) is available: HERE

The updated guidance contains 18 new questions, including what to do if you cannot locate an appropriate EMDN code.

Question	Answer
9. What EMDN code should I assign to my device’s UDI-DI if I can’t find an appropriate EMDN term?	The user should always search the most granular (lowest) levels of the nomenclature for the most appropriate EMDN term for the device’s UDI-DI in question. It remains the sole responsibility of the manufacturer to review the entire nomenclature for the identification of the most appropriate term to report. Only if the most granular levels do not match the device’s description, the manufacturer may assign the code extension ‘99’ which refers to ‘other’ within that level type.   Note: UDI-DIs1 associated with code extension ‘99’ are subject to additionally scrutiny during the annual EMDN review procedure.”
10. What should I do if there is no appropriate code to assign to my device’s UDI-DI?	a) assign the code extension 99 (term ‘Other’) to the device, as indicated in Question 9,  b) make a proposal in the EMDN submission platform or through the MDCG Nomenclature WG for the creation of a new level (code and term), providing a thorough description of the device in question. Manufacturers are also encouraged to notify of such potential new code needs early in the certification process.  c) once/if a new code is created, manufacturers must reflect this change and update their registration in EUDAMED and in all related regulatory documentation (see Question 23)
13. Will there be a notification to impacted users of the changed codes?	Notifications to users is not currently possible. Publications of the final annual revisions will be available on the European Commission’s MDCG endorsed documents and other guidance website page.
16. Will there be a set timeframe where feedback / questions will need to be addressed by the requester / submitter in order to meet the same calendar year processing time?	The timeframe is 15 working days for clarification after the request from EMDN-Technical Team mailbox, if the clarification arrives after the deadline date, the proposal may not be processed in the same calendar year.
23. What happens in EUDAMED in case of changes to EMDN related to codes rendered obsolete or split?	Codes which are rendered ‘obsolete’ will not be immediately deleted from EUDAMED and will remain visible for at least 5 years from the date of their obsolescence. While the codes will still be displayed in during that a 5-year cycle (maximum certificate lifespan), manufacturers will no longer be able to use obsolete codes for device registration or updates to existing registrations. An archive with obsolete codes and related information such as date and reason for obsolescence will be maintained and kept publicly available to all.   Codes which are split will remain visible but, since they are no longer terminal codes, they will not be available for device registration or updates to existing registrations. An archive with split codes and related information such as date and justification for splitting, will be maintained and kept publicly available to all.
24. In case of changes in EMDN (new codes, split codes, obsolete codes), when do manufacturers need to update the relevant code(s)?	Manufacturers and notified bodies, as appropriate, are expected to reflect such updates, as relevant, within different documentations (e.g. certificates, declaration of conformity) and in EUDAMED in a timely manner and reasonable manner, and at the latest prior to the next annual surveillance audit following the finalisation of the annual EMDN update cycle. Since individual contact is not foreseen, it is therefore recommended that manufacturers make a standard practice to assess each annual publication of EMDN for any changes which may impact devices in their product portfolio, in order to notify their notified bodies ahead/during their annual surveillance audit.