MDCG 2025-2: EMDN 2024 submissions and annual revision outcome, explained

Who this applies to

This document is useful if you submitted an EMDN change in 2024, maintain UDI or Eudamed master data, or need to understand why a device sits under a particular nomenclature term. It is also a useful precedent file for anyone preparing a future annual-revision submission.

It is not new classification guidance. EMDN describes devices for registration and regulatory data exchange; it does not determine qualification under the MDR or IVDR, and it does not assign a risk class.

What the document contains

MDCG 2025-2 is a presentation of the 2024 consultation outcomes. It groups proposals by result and gives examples of the reasoning applied by the EMDN team and MDCG Nomenclature Working Group.

The accepted and partly accepted examples cover a broad mix: reusable gastrointestinal dilators for home therapy, diagnostic arrhythmology catheters, pulsed-field and laser-ablation catheters, phonation valves, reusable urology instruments, arthroscopy instruments, an implantable radiation spacer, prepared culture-media bottles, Candida auris nucleic-acid reagents, power-assisted rollators and magnetoencephalography systems.

The examples matter more than the volume of slides. They show that a proposal is assessed against the whole hierarchy: whether the concept is technically distinct, whether a broader term already fits, whether the requested level is structurally appropriate, and whether the evidence supports a reusable nomenclature concept rather than one product.

Why proposals were rejected

The rejection examples fall into a few repeatable patterns:

• Not enough technical information. The submission did not explain the device or the distinction it was asking EMDN to encode.
• An existing term already covers it. EMDN does not need a separate leaf for every commercial or clinical variation.
• The requested level was wrong. A proposed term may make sense technically but not at the category, group or type level requested.
• The change would break the hierarchy. EMDN is a structured tree; a locally convenient addition can create overlap or inconsistency elsewhere.
• The request was outside nomenclature scope. Classification, qualification, reimbursement and market positioning are not solved by adding an EMDN code.

That makes MDCG 2025-2 especially useful before the next consultation: it tells you what evidence and framing are likely to survive review.

Do not use this as the change log

The presentation describes decisions and examples, but it is not the authoritative row-by-row implementation list. MDCG 2025-3 is the accompanying spreadsheet containing the inserted, modified, deleted and split terms.

This distinction prevents a common data-quality mistake: updating internal systems from the wording of a proposal rather than from the term that was actually published. A partly accepted proposal may result in a different code, name or hierarchical solution.

What this means for you, practically

1. Check whether your proposal was accepted in principle. Read the rationale in MDCG 2025-2, especially if the answer was “partially accepted”.
2. Take production data from MDCG 2025-3. Match the final code, term, change type and additional information before changing your device master.
3. Assess downstream impact. An amended parent term can affect search behaviour and coding decisions even when your current leaf code remains unchanged.
4. Keep qualification and classification separate. Document the EMDN update in the UDI/Eudamed workstream; do not use it as evidence for an MDR or IVDR classification change.
5. Use the rejection logic for future submissions. Explain the unmet nomenclature need, the devices that would share the term, the proposed place in the hierarchy, and why existing terms are insufficient.