MDCG 2026-1: EMDN 2025 submissions and annual revision outcome, explained
The outcome of the 2025 EMDN annual revision cycle: which nomenclature change requests were accepted, partially accepted, or rejected — and why.
Every year, anyone can propose changes to the European Medical Device Nomenclature (EMDN) — new codes, edits, moves — through a public consultation. MDCG 2026-1 publishes the outcome of the 2025 cycle: each submission is listed as accepted, partially accepted, or not accepted, with a rationale. If you proposed a code or your device sits in an affected category, this is where you find out what happened.
Who this applies to
Manufacturers (and other stakeholders) who submitted EMDN change requests in the 2025 public consultation, and anyone whose devices are classified under EMDN categories touched by the accepted changes. Every device registered in EUDAMED carries an EMDN code, so nomenclature changes ripple into registrations.
What the document contains
The document — a slide deck from the MDCG's Nomenclature Working Group — sorts every 2025 submission into three outcomes:
- Accepted — the request enters the nomenclature.
- Partially accepted — for example, a new code is created, but at a different hierarchy level than the submitter proposed.
- Not accepted — typically because the request lacked sufficient technical detail for evaluation, asked to insert a level that already exists, or proposed a structure incompatible with the nomenclature's rules.
Each rejected entry lists the affected code, the submitter's supporting information, and the rationale. The examples are useful reading before you resubmit because they show what information was missing or why a request fell outside the update process.
What this means for you, practically
- Check your categories. If your devices sit under codes touched by accepted changes, see MDCG 2026-2 (the change log) and MDCG 2026-3 (the version history) for what exactly changed, and verify your EUDAMED registrations still carry the right codes.
- Resubmit with substance. If your proposal was rejected for insufficient information, the annual cycle (and the ad hoc procedure in MDCG 2025-1) lets you try again — with the technical detail the working group asked for.
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