When does EUDAMED become mandatory and what are the implications of Decision (EU) 2025/2371?

For years, EUDAMED has been “the great European database” that everyone is talking about in the medical device sector. Commission Decision (EU) 2025/2371, published on 27 November 2025, marks a decisive step for the database, as four key modules are officially declared functional, triggering the countdown to mandatory use across the European Union.

For manufacturers, their QARA teams, their PRRCs (Person Responsible for Regulatory Compliance) and consultants, this has very real implications, including actor registration, UDI (Unique Device Identification) management, increased public visibility and stricter traceability requirements. EUDAMED is no longer a distant concept; it is becoming a daily compliance tool.

What are the key points to take into account?

• EUDAMED serves as the EU’s central database for medical devices, structured around 6 modules including UDI/Devices.
• Decision (EU) 2025/2371 confirms the full functionality of 4 modules: Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance.
• In accordance with Regulation 2024/1860, publication in the Official Journal of the EU (OJEU) triggers a 6-month countdown, after which these 4 modules will become mandatory from 28 May 2026.
• The Vigilance and CI/PS modules will follow, with mandatory implementation expected after 2026 according to the Commission’s roadmap.
• PRRCs and QARA teams should initiate an EUDAMED project immediately, addressing UDI strategy, data quality, governance, tools, and ensuring accurate translation of information into all market languages.

What is EUDAMED and what are its objectives for medical devices?

EUDAMED is the European database for medical devices established under the MDR (2017/745) and the IVDR (2017/746). Its purpose is to provide a “live” view of the lifecycle of devices placed on the EU market: actors, device registration, certificates, clinical trials, vigilance and market surveillance.

How is EUDAMED structured and what purposes do its modules serve?

EUDAMED is made up of 6 interconnected modules:

• Actor registration: registration of manufacturers, authorised representatives, importers (and allocation of the SRN).
• UDI/Device registration: registration of devices, managed through the UDI system.
• Notified Bodies and Certificates: information on MDR/IVDR certificates.
• Clinical Investigations & Performance Studies (CI/PS).
• Vigilance & Post-market surveillance.
• Market Surveillance: actions carried out by the competent authorities.

Main objectives:

• Transparency for patients and healthcare professionals.
• Better traceability and risk management.
• Stronger coordination between Member States.
• Relative simplification of the communication between authorities, manufacturers and notified bodies.

Why is the UDI system the gateway to EUDAMED?

The UDI (Unique Device Identifier) system entails a unique numeric or alphanumeric code designed to unambiguously identify a device on the market and facilitate its traceability. It is made up of:

• a UDI-DI (Device Identifier) linked to the model;
• a UDI-PI (Production Identifier) linked to the lot, expiration date, etc.

Under the MDR, the UDI becomes the backbone of device identification:

• Every device (with some exceptions) must have a UDI.
• The associated data must be uploaded to EUDAMED (UDI/Devices module).
• The Basic UDI-DI – or EUDAMED-DI for some “legacy devices” – is the key to many regulatory functions. (Wikipedia)

For example, for a manufacturer based in France selling products in Germany and Spain, this means that the same UDI logic feeds device labelling, internal systems (ERP, PLM) and EUDAMED registration, while ensuring consistency across multiple languages.

How does EUDAMED change the day-to-day life of manufacturers in Europe?

Even before the general obligation, EUDAMED:

• is already an official source for authorities and notified bodies;
• structures the processes of SRN, UDI and MDR/IVDR certificates;
• influences the expectations of hospitals and distributors regarding the quality of product data.

Specifically:

• A French manufacturer of implantable medical devices expanding its market to Belgium must have full control over the granularity of its UDI data.
• An IVD manufacturer in Italy working through an importer in Spain will need to align EUDAMED, IFU and multilingual catalogue information.

How does Decision (EU) 2025/2371 affect EUDAMED, and what are the new timelines?

Decision (EU) 2025/2371 is the legal trigger that was missing. It confirms that several EUDAMED electronic systems are functional and that they meet their specifications.

Which EUDAMED modules are now officially functional?

Following an independent audit, the Commission has confirmed that the following modules are now functional:

• Actors: registration of economic operators.
• UDI/Devices: database of devices and their UDIs.
• Notified Bodies & Certificates: management of certificates, including MDR/IVDR.
• Market Surveillance: actions and measures taken by the competent authorities.

It is precisely these four modules that will first become mandatory.

When does the use of EUDAMED become mandatory?

Regulation 2024/1860 introduced a new logic whereby each module becomes mandatory 6 months after the publication of its full-functionality notice in the OJEU, without waiting for the entire database to be completed.

The Commission’s official page summarises the situation as follows: 

• Decision (EU) 2025/2371 was published on 27 November 2025.
• The 6-month period starts on this date.
• As of 28 May 2026, the following modules are mandatory:
  • Actor registration;
  • UDI/Device registration;
  • Notified Bodies & Certificates;
  • Market Surveillance.

The Vigilance & PMS and CI/PS modules are still under development. According to the Commission’s roadmap (July/November 2025), the full-functionality notice for the Vigilance module is expected in Q4 2026, with mandatory implementation roughly six months thereafter (Q2 2027); these dates remain subject to revision. (Public Health)

What are the main dates for PRRCs and QARA teams to keep in mind?

For a PRRC or a QARA professional, the timeline can be summarised as follows:

• 27 November 2025
  • Publication of Decision (EU) 2025/2371 and confirmation of the functionality of the first 4 modules.
• 28 May 2026
  • Start of mandatory use of the Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance modules.
• 2026–2027 (forecast)
  • Publication of the full-functionality notice for Vigilance & PMS (expected by the end of 2026) then mandatory use about 6 months later (around mid-2027), according to the current roadmap.
• End of the transition periods for device registration
  • Existing documentation and national registrations must be migrated to EUDAMED, according to the Commission’s detailed schedule, based on risk class and length of time on the market.

The bottom line is that the “EUDAMED project” is no longer optional for manufacturers, but a key QARA priority for 2026–2027.

Why is this step critical, and what is the next step for manufacturers?

What are the specific risks in case of EUDAMED non-compliance?

Being unprepared for EUDAMED can lead to:

• inability or delay in device registration, and consequently in placing devices on the market;
• inconsistencies between EUDAMED data, device labelling and IFUs, potentially resulting in non-conformities during audits;
• lack of UDI traceability, complicating recalls or vigilance investigations;
• loss of credibility with distributors, hospitals and authorities.

For a French manufacturer selling class IIb devices in Poland and Portugal, a delay in registration or an inconsistent UDI can block orders, create logistical costs and generate negative signals to national authorities.

What action plans should PRRCs and QARA teams start implementing now?

PRRCs and QARA teams can structure their action plan around a few key areas:

• EUDAMED governance
  • Appoint an EUDAMED Project Owner (often linked to the QARA team).
  • Define roles: who creates the UDIs, who validates the data, and who uploads to EUDAMED.
• Data mapping & quality
  • Inventory of devices, Basic UDI-DI, versions, packaging, GMDN/CND codes.
  • Cleaning of existing data (ERP, PLM, Excel files).
  • Alignment of commercial names across all market languages.
• UDI strategy & process
  • Choice and management of the UDI issuing body (GS1, HIBCC, etc.). (Wikipedia)
  • Internal rules for creating new UDI-DI/UDI-PI codes.
  • Update procedures in case of significant changes.
• Tools & IT integration
  • Decision between manual entry, M2M connectors or specialised EUDAMED solutions. (MedTech Europe)
  • End-to-end testing (from UDI creation to EUDAMED upload).
• Training & support
  • Training for RA/QA, Supply Chain, IT, and Marketing teams on the impact of EUDAMED.
  • Ensuring top management is informed about the potential risks associated with delays.

How can linguistic and documentation aspects be anticipated through translation?

EUDAMED requires strict consistency between:

• the data recorded in the database (device name, intended use, essential warnings);
• IFUs, leaflets, labels, patient cards, clinical safety summaries;
• the documents submitted to authorities (clinical files, responses to authorities, vigilance communications).

However, this content often needs to be prepared in multiple EU languages (French, German, Spanish, Italian, etc.). Poor translation can lead to:

• discrepancies between the EUDAMED description and the local IFU;
• misunderstandings for authorities or notified bodies;
• additional difficulties during recalls or vigilance actions.

This is where a specialised partner like AbroadLink Translations can add real value:

• Technical and regulatory translation of device descriptions, indications, warnings.
• Terminology harmonisation relating to the UDI, including product family name, references, accessories, etc.).
• Multilingual management of clinical safety summaries, implant cards and vigilance communications.
• Creation of translation memories and glossaries specific to each manufacturer to ensure long-term consistency.

How can AbroadLink Translations support your EUDAMED compliance?

EUDAMED compliance encompasses regulatory, technical, and linguistic dimensions. You can internalise your UDI processes and IT flows, but high-quality multilingual communication is still key to how your devices are perceived across EU markets.

AbroadLink Translations can help you:

• secure the translation of all your EUDAMED-related regulatory MDR/IVDR content;
• harmonise the names of devices, product families and accessories between your internal databases, your catalogues and EUDAMED;
• support your PRRCs and QARA teams in preparing clear, consistent, and audit-ready files.