MDCG 2025-1: EMDN ad hoc procedure, explained

Who this applies to

This form is for national competent authorities and notified bodies submitting an ad hoc European Medical Device Nomenclature (EMDN) request. Manufacturers do not submit it directly. If you manufacture the affected device, your job is to give the authority or notified body enough technical and regulatory information to make a defensible request.

The form asks whether the request is needed for registration in Eudamed's UDI-DI module, why it should be assessed through the ad hoc procedure, and why the existing codes cannot be used. It does not answer whether a product is a medical device or which risk class applies.

What this document actually is

MDCG 2025-1 is a two-page form, not a guidance narrative. It standardises the information that the EMDN team needs before it can assess an urgent request. The completed form is sent to the Commission's EMDN mailbox at [email protected].

All fields are mandatory except field 13, which is for additional supporting information. The form asks for four groups of information:

The form also asks whether the device is novel, whether an expert panel has assessed it, and whether similar devices or technologies might need the same code. That last point matters: EMDN codes describe groups of devices, not one manufacturer's catalogue item.

What the request must demonstrate

The hard part is not filling in the form. It is demonstrating the established need for an ad hoc assessment and explaining why the current nomenclature cannot accommodate the device.

In practice, prepare a short search record showing which EMDN version you checked, which terms you considered, and the technical or intended-purpose reason why the closest codes do not fit. That gives the authority or notified body the information it needs to complete the form.

The request should also distinguish between three questions that are often mixed together:

1. Qualification: is the product a medical device or IVD?
2. Classification: which MDR or IVDR risk class applies?
3. Nomenclature: which EMDN code describes the device for registration and regulatory data exchange?

An EMDN request answers only the third question. A new code does not decide whether the product is a device and does not change its risk class.

What this means for you, practically

1. Search before escalating. Record the EMDN version searched, the terms and synonyms used, and the closest codes considered. Give that search record to the authority or notified body.
2. Explain the need precisely. Identify the device and UDI-DI registration affected, why the existing code set cannot describe it, and why the request should use the ad hoc procedure.
3. Write a technology description, not a sales pitch. Cover the operating principle, intended purpose, users, patient population, specimen or body site where relevant, and the characteristics that distinguish it from neighbouring EMDN concepts.
4. Propose a place in the hierarchy. Suggest the category, group and type-level term, but expect the EMDN team to change the wording or placement. Include comparable devices that should logically share the code.
5. Route the request correctly. Provide the evidence package to your competent authority or notified body. One of those organisations completes and submits MDCG 2025-1; the manufacturer does not send the form as its own application.