MDCG 2024-2 is available for download: HERE
It provides an overview of:
EMDN codes are required to meet several MDR/IVDR requirements. Most notably, EMDN codes are required to register medical devices in EUDAMED.
As needs arise, EMDN codes may need to be newly created, amended, or obsoleted. For example, manufacturers may need to request a new EMDN code in order to fulfill their registration obligations.
Below is how these changes will be made.
The term “Actor” is most well-known as it relates to EUDAMED. Per the EU Commission’s EUDAMED Actor Roles Fact Sheet:
“An actor is a natural or legal person (organisation) with a specific role that has to be registered in EUDAMED.”
MDCG 2024-2 outlines EMDN Actors as those involved with the creation, maintenance, and/or use of EMDN codes.
EMDN code requests may be submitted by any user, including but not limited to: notified bodies, manufacturers, trade associations, the World Health Organization, authorized representatives, importers, and distributors.
An expert group that supports EMDN implementation issues. It is made up of representatives from the national Competent Authorities, economic operators, healthcare professionals, notified bodies, hospitals, laboratories, patients, and consumers.
A smaller technical group established under the Nomenclature Working Group (WG). They are involved in the maintenance of EMDN codes, including the definition of new codes and revisions to existing codes. These are then presented to the Nomenclature WG for consideration.
All parties that may use EMDN codes, including competent authorities, notified bodies, manufacturers, authorized representatives, importers, distributors, trade associations, hospitals, patients, and more.
Actors can request new EMDN codes at any time. However, the EMDN Technical Team will only review the requests once per year. This means, in some cases, it may take nearly two years for a user’s request to be processed. For example, if a request is submitted February 2025, a decision would be published December 2026.
The general process is outlined below. However, note that MDCG 2024-2 gives room to change the process, depending on the volume of requests.
The requests submitted throughout the year will be collected. For your request to be processed in the same calendar year, you must submit it by 31 January of that year. Otherwise, it will processed the following January.
The EMDN Technical Team will review the pending requests, and the general usage of EMDN codes in EUDAMED.
Upon completion of its evaluation, a proposal for EMDN updates will be presented to the Nomenclature Working Group. This may include the creation of new codes, amendments, obsoleting codes, and/or rejection of proposed new codes.
The Nomenclature Working Group will provide feedback and endorse a final draft of changes.
The final draft is endorsed by the Medical Device Coordination Group (MDCG) and the updates are published.
Meanwhile, after the endorsement, translations into all EU national languages are validated by the Nomenclature Working Group.
MDCG 2024-2 does not outline the process for users to request a new EMDN code.
If you need a new or amended code, instead please read: How do I request a new EMDN code?
MDCG 2024-2 stresses that the above is the standard process. However, they are piloting a procedure for ad hoc requests.
Ad hoc requests will also be assessed by the EMDN Technical Team and then circulated to the Nomenclature Working Group for review and endorsement.
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