28 May 2026 made EUDAMED mandatory. 27 November 2026 closes the door for devices already on the market. What has to be registered, and five steps to get there.
Since 28 May 2026, the first four EUDAMED modules (European Database on Medical Devices) have been mandatory. Most teams have treated that deadline as a new-product matter: you register what you launch. The portfolio already on the market has often stayed outside the scope of the project.
Yet that is exactly what the next deadline covers. Devices placed on the market before 28 May 2026 must be registered in the UDI/Devices module by 27 November 2026 at the latest, twelve months after the Commission decision was published in the Official Journal. You have a little under four months left.
Regulation (EU) 2024/1860 amended the MDR (Medical Device Regulation, Regulation (EU) 2017/745) and the IVDR (In Vitro Diagnostic Regulation, Regulation (EU) 2017/746) to allow EUDAMED to be rolled out module by module, rather than switched on in a single block. Each module becomes mandatory six months after the Commission declares it functional.
Decision (EU) 2025/2371 of 26 November 2025, published in the Official Journal on 27 November 2025, declared four modules functional: actor registration, UDI/Devices, notified bodies and certificates, and market surveillance. Hence 28 May 2026 for the general obligation, and 27 November 2026 to catch up on the existing stock.
One useful clarification: some national communications, including the French ANSM, refer to 28 November 2026 for the same deadline. The difference comes from how the period is counted. In practice, aim for the earlier date and treat 27 November 2026 as the point by which everything must be entered.
A device missing from EUDAMED is visible. Part of the database is publicly accessible. Your distributors, hospital buyers and market surveillance authorities can check in seconds whether a reference is registered. A gap in the database becomes a commercial obstacle before it becomes a compliance finding.
The data workload is routinely underestimated. A registration is not one line per product, but a set of attributes for each commercial reference: Basic UDI-DI, UDI-DI, risk class, nomenclature code, market status, link to the certificate. A portfolio of fifty references quickly means several thousand fields to consolidate, decide on and validate.
The responsibility cannot be delegated. Device registration falls to the manufacturer, wherever it is established. The authorised representative (Article 11 MDR) and the importer (Article 13) have their own registration and verification duties, but they do not stand in for the manufacturer. Relying on a European partner to absorb the topic is the single most common source of delay.
1. Confirm your SRN and your roles. The Single Registration Number (SRN) issued by the Actors module is the key to every other module. A group holding several roles, manufacturer and importer for instance, needs a separate account for each role. Check that contact details and the person responsible for regulatory compliance are current: an SRN obtained in 2024 and never reviewed often carries outdated information.
2. Inventory what is genuinely on the market. The scope is wider than the list of commercially active products. It covers every reference still made available in the Union, including software versions maintained at existing customer sites and devices still marketed under a directive certificate (MDD or AIMDD) through the transitional provisions of Article 120 MDR. These legacy devices are registered using EUDAMED's dedicated identifiers, described in guidance MDCG 2019-5.
3. Prepare the data before opening the interface. Build a single reference table gathering, for each product, the attributes expected by the UDI/Devices module. This is where inconsistencies surface: a risk class that differs between the technical documentation and the catalogue, a trade name that does not match the certificate, an EMDN nomenclature code never settled. Resolving these in a spreadsheet costs a few hours; resolving them after data entry costs line-by-line rework.
4. Register, then check that the links hold. Data entry is only complete once each device is correctly linked to its certificate, its notified body and, for non-EU manufacturers, its authorised representative. A reference that is registered but orphaned from any certificate remains a red flag for a surveillance authority. Budget time for that cross-check, not only for the entry itself.
5. Put database upkeep into your QMS. EUDAMED is not a one-off project. Every product range change, every certificate change, every market withdrawal has to be reflected. Write a procedure into the Quality Management System (QMS), name an owner, and connect EUDAMED updates to your existing change control and post-market surveillance processes. Without that, the database will be out of date again within eighteen months.
28 May 2026 opened the obligation; 27 November 2026 closes it for existing devices. Any device placed on the market before May 2026 and still commercialised must appear in the UDI/Devices module by that date, devices under the directives included. The difficulty is not regulatory, it is logistical: consolidating scattered product data, settling long-standing inconsistencies and entering significant volume in a short window. Organisations that treat this as a data project, with an inventory, a reference table and a named owner, close it in a few weeks. The others discover in November that half their attributes exist nowhere in usable form.
Sparta Care supports healthcare software and AI system manufacturers with their European registration obligations:
Contact us to secure your 27 November 2026 deadline.
