For the first four modules, EUDAMED is no longer merely a preparatory digitalisation topic. The European Commission states that these modules have been mandatory to use since 28 May 2026. This followed the publication of Commission Decision (EU) 2025/2371: the Decision is dated 26 November 2025 and was published in the Official Journal of the European Union on 27 November 2025. The prescribed six-month transition period began with that publication.
Which four modules are affected
Exactly these four EUDAMED modules are mandatory:
- Actor registration
- UDI/Devices
- Notified Bodies & Certificates
- Market Surveillance
The Decision confirms that these electronic systems are functional and meet the relevant functional specifications. It does not, however, replace an assessment of the specific obligation under the MDR or IVDR for a particular role, product or activity.
Why this matters operationally for medical technology companies
For manufacturers, authorised representatives, importers and other economic operators, the quality of data, roles and processes becomes immediately important. Registration and master data, UDI and product information, certificate references, and the handling of regulatory activities must fit the respective area of responsibility. System access alone is not sufficient if roles, accountabilities, approvals and data sources have not been clarified within the organisation.
A robust working position therefore separates three questions: who is the economic operator in the relevant case? Which information and evidence belong in the process? And who reviews discrepancies, missing information or escalations? The answers are organisation- and product-specific; they should not be inferred from a general news item.
Relevance for hospitals: not an automatic registration obligation
The obligation to use these four modules does not mean that every hospital is itself required to register in EUDAMED. Hospitals and other care providers may nevertheless be affected because their procurement, quality and risk processes can depend on reliable information about products, suppliers and certificates.
In practice, the relevance often sits at the interfaces: selecting and approving suppliers; checking certificate information; maintaining product and UDI master data; and deciding how notices or discrepancies are escalated internally to procurement, medical technology, quality management and, where appropriate, the manufacturer. If an institution itself holds an economic-operator role, for example for a particular activity, that role must be assessed separately.
Four sensible checks
1. Define roles and touchpoints
Document which internal units and external partners are involved in procurement, product data, quality, vigilance or regulatory communication. This makes visible where EUDAMED information actually feeds into decisions and who must be able to act when questions arise.
2. Make product and UDI master data connectable
Check whether product identification, UDI-related information and internal master data can be found consistently. The objective is not a blanket data migration, but a traceable comparison for the products and processes that the organisation is responsible for or uses.
3. Embed supplier and certificate checks in the workflow
Define which information is checked before procurement, approval or change, which source is authoritative and how missing or contradictory information is handled. This links regulatory information to the operational procurement process.
4. Prepare escalation and evidence
Set out to whom inconsistencies are passed, which documentation is retained and when specialist functions are involved. A clear boundary between internal plausibility checks and legal or regulatory assessment is especially important.
Conclusion: treat EUDAMED as a process question
Since 28 May 2026, mandatory use of the first four EUDAMED modules has been a concrete regulatory framework. For medical technology companies, roles, data quality and responsibilities come to the fore. For hospitals, the focus will often be on reliably incorporating relevant information into procurement, supplier and certificate checks, product and UDI master data, and escalation routes. No automatic registration obligation for every hospital can be inferred from this.
The next sensible step is a structured inventory of the organisation's own roles, data flows and interfaces. It provides a basis for specialist assessment of the applicable requirements without pre-empting a legal assessment of an individual case.
Primary sources and scope of validity
- European Commission: The EUDAMED four first modules will be mandatory to use as from 28 May 2026. Confirms the Decision of 26 November 2025, publication in the Official Journal on 27 November 2025, the six-month transition period, the start on 28 May 2026 and the four named modules.
- European Commission: Getting ready. Official preparation page for mandatory use of the first four EUDAMED modules.
- Commission Decision (EU) 2025/2371. Official legal act on functionality and fulfilment of the functional specifications of the four electronic systems.