MDCG 2026-2: 2025-2026 annual revision change log, explained
The consolidated change log of the 2025–2026 EMDN annual revision: every code insertion, modified term, deletion and split, in one spreadsheet.
MDCG 2026-2 is the change log of the 2025–2026 EMDN annual revision — a spreadsheet containing 135 changes: 74 inserted codes, 48 modified terms, 12 deletions and one modified-and-split term. It is the operational companion to MDCG 2026-1: this is the file you compare with your device portfolio to see whether an EMDN code or term you use has changed.
Who this applies to
Anyone maintaining EMDN codes in device registrations: regulatory teams keeping EUDAMED records current, and software vendors mapping the nomenclature. The EMDN code is a required attribute of every device registered in EUDAMED, and it also drives sampling by notified bodies and market analysis by authorities.
What the document contains
Unlike most MDCG documents, this is not a PDF but a spreadsheet. Its 135 rows contain 74 insertions, 48 modified terms, 12 deletions and one modified-and-split term. Each row shows the v.2026 term, the type of action, the previous term where applicable, and additional information about the change. The rationale behind the changes lives in MDCG 2026-1; the complete resulting nomenclature, version by version, is MDCG 2026-3.
What this means for you, practically
- Compare your portfolio once per cycle. Filter the change log against the EMDN codes you use, then assess whether affected registrations or internal reference data need to be updated.
- Update internal systems too. QMS records, technical documentation, and any integrations that store EMDN codes should follow the same revision — a stale code is a small but avoidable audit finding.
Turn templates into working QMS documents.
Start from OpenRegulatory templates, fill them out with AI assistance, and keep them connected to your QMS in Formwork.