Eudamed timelines are now real, what this mdr update means for your labeling and translations

Dec 06, 2025

The European Commission has now formally confirmed that four key electronic systems in EUDAMED are functional and meet the required functional specifications. This is not a general announcement, it is a legal trigger that starts the MDR/IVDR “transition clock” for obligations linked to these systems. (EUR-Lex)

What was published, and what exactly it confirms

On 27 November 2025, the Official Journal published Commission Decision (EU) 2025/2371 (adopted on 26 November 2025). (EUR-Lex)

The Decision confirms functionality for these four EUDAMED systems: (EUR-Lex)

actors registration (economic operators)

udi database and device registration

notified bodies and certificates

market surveillance

This confirmation is based on an independent audit and the Commission’s verification that these systems meet the functional specifications. (EUR-Lex)

What “transition clock” means (and what the Decision actually says)

The Decision explicitly states that, under MDR and IVDR, the transition periods for obligations and requirements related to these electronic systems start from the date of publication of this Decision. (EUR-Lex)

It also states the Decision enters into force on the day of its publication. (EUR-Lex)

What we are not doing in this article: listing downstream “end dates” per obligation. Those dates are not stated inside the Decision text itself. The Decision is the official “starting gun”, the length of each transition period and which obligations it affects are defined in the MDR/IVDR articles referenced by the Decision. (EUR-Lex)

Why this impacts translation, even if eudamed is “data”, not “documents”

EUDAMED entries don’t exist in isolation. In real life, they must align with the regulated content your teams already manage, across product and portfolio documentation.

As EUDAMED use becomes mandatory for the relevant obligations (after the applicable MDR/IVDR transition periods), companies typically face a bigger operational pressure: consistency across systems and documents.

For translation and labeling teams, that usually shows up as:

tighter control of trade names and model naming

stronger need for consistent device descriptions and intended purpose wording

more frequent small updates at scale (portfolio-wide changes, not one document at a time)

less tolerance for “acceptable variants” across languages, because data and documentation must stay aligned

(Those are practical implications for operations and inspections; they are not wording quoted from the Decision, but they are the most common documentation consequences we see when regulatory systems become enforceable and interconnected.)

The most common translation-sensitive risk areas to address now

1) Trade names and device naming across languages

Many organizations accidentally allow marketing-led drift: the trade name or model naming changes slightly in one market or language.

What helps:

an approved list of do-not-translate items (trade names, model names, identifiers)

a controlled naming convention for product families and variants

one reference “source of truth” that translators and local teams must follow

2) Intended purpose and key regulated statements

In MDR/IVDR work, minor wording shifts can become major review discussions.

What helps:

a locked, approved wording set for intended purpose, indications/claims, warnings, contraindications

terminology governance (approved terms + forbidden synonyms) across all EU languages you publish in

3) Cross-document alignment at scale

The workload is rarely “just the IFU”. It is a network:

labels, IFU, DoC, certificates/annexes, packaging content, and internal master data exports

What helps:

translation memory and termbase built specifically for your portfolio

structured QA focused on regulated content (terminology compliance, numeric consistency, controlled phrases)

What to expect next (translation workload patterns)

Because the Decision starts the transition periods for obligations linked to the four systems, organizations commonly respond by accelerating:

template and labeling standardization

terminology clean-up and harmonization across legacy content

portfolio-wide updates to reduce variation before regulatory milestones arrive

The companies that struggle most are not the ones with the most languages. They are the ones with inconsistent legacy phrasing across documents, products, and regions.