MDCG 2025-3: 2024-2025 annual revision change log, explained

Who this applies to

This spreadsheet is for anyone who maintains EMDN assignments: manufacturers, authorised representatives, importers, notified bodies, competent authorities and teams responsible for UDI/Eudamed or regulatory master data.

If your codes are outside the affected branches, the file may produce no action. You should still retain the assessment: EMDN is versioned reference data, and “reviewed, no affected codes” is a better controlled outcome than silently assuming nothing changed.

What changed in the annual revision

MDCG 2025-3 contains 153 change records in a single worksheet. The change types are:

The changes are not evenly distributed. Category W (in-vitro diagnostic devices) accounts for 74 rows, and category X (devices without an intended medical purpose listed in MDR Annex XVI) for 29. Other changes appear across implantable, dental, reusable surgical, rehabilitation and miscellaneous device branches.

Examples include new terms for pulsed-field and laser-ablation catheters, changes around diagnostic arrhythmology catheters and phonation valves, new Candida auris reagent terms, magnetoencephalography systems and additions for Annex XVI product groups.

How to read the spreadsheet

Treat each row as a controlled change record, not as prose guidance. Read the code, term, change type and additional-information fields together. The hierarchy matters: a code marked as non-terminal describes a branch, while a terminal code is ordinarily the selectable endpoint used to identify a device.

Three cases need different handling:

1. Term modified, code unchanged. Update labels in internal reference data, translations and search synonyms, but do not create a false device change merely because the nomenclature wording improved.
2. Code deleted or split. Determine the replacement for each affected product. A split cannot safely be handled as a bulk one-to-one substitution; the device characteristics decide which new branch applies.
3. New, more specific code inserted. Reassess whether a device currently mapped to a broader code should use the new term for future registration or record maintenance. Document the rationale and the effective EMDN version.

Do not assume that a manufacturer catalogue number, Basic UDI-DI or UDI-DI is interchangeable with an EMDN code. They serve different purposes and have different change triggers.

Relationship to MDCG 2025-2

MDCG 2025-2 explains how the 2024 proposals were assessed: accepted, partly accepted or rejected. MDCG 2025-3 records what was actually implemented.

Use the two together when the reason for a change matters, but let the spreadsheet drive your controlled data update. In particular, never copy a submitter's proposed term into Eudamed simply because the underlying request was accepted; the final EMDN solution may use different wording or a different place in the hierarchy.

What this means for you, practically

1. Export your current EMDN assignments. Compare codes against the change log, including parent branches that may affect searches or internal rules.
2. Classify every match. Separate label-only updates from deletions, splits and newly available specific terms; they need different approvals and implementation steps.
3. Review product by product where a code split. Do not bulk-map the old code without checking the characteristics behind the new terms.
4. Update connected systems together. Your regulatory master, Eudamed work instructions, UDI data feeds, distributor data and controlled code lists should not drift onto different EMDN versions.
5. Keep an audit trail. Record the old and new values, EMDN release, rationale, approval and implementation date. Do not rewrite historical submissions in a way that obscures which code was valid when they were made.