EUDAMED is the European Commission’s electronic database for medical devices, established under Article 33 of Regulation (EU) 2017/745 (MDR). Registration records two layers in the database: an actor record that identifies the economic operator (your company or its authorised representative), and device records that identify each Basic UDI-DI family and the UDI-DI under it. Two deadlines now bind manufacturers placing devices on the EU market: 28 May 2026 for new-device registrations under MDR Article 29, and 28 November 2026 for legacy devices already on the market under the Article 120 transitional regime. This page is the overview of the topic: which actor your company is in EUDAMED’s vocabulary, which modules a device passes through, which identifiers each device carries, and how the prepared data reaches the EC portal. The deadlines themselves, including the retrospective split, sit on the 28 May 2026 and 28 November 2026 registration deadlines page.
What EUDAMED is and which devices need to register
EUDAMED is the EU electronic database for medical devices, established under MDR Article 33, where manufacturers, authorised representatives, and importers record actor and device information and where notified bodies record certificate decisions. The same database serves the in vitro diagnostic regime under IVDR Article 26. Six functional modules sit inside one database; the manufacturer-facing modules are Actor and UDI/Devices.
Device-registration scope is set by MDR Article 29 (and IVDR Article 26 for IVDs). It covers every device placed on the EU market that is in scope of the MDR or IVDR: Class I, IIa, IIb, and III devices under MDR, and IVD classes A, B, C, and D under IVDR. System and procedure packs registered under MDR Article 22 carry their own record. Custom-made devices under MDR Article 2(3) are registered on a simplified path under MDR Article 21(2). Devices placed on the market under the predecessor directives (MDD 93/42/EEC, AIMDD 90/385/EEC, IVDD 98/79/EC) are legacy devices. They follow the registration regime in Implementing Regulation (EU) 2024/1860, with the device-record scope narrowed by Commission Decision (EU) 2025/2371. The retrospective treatment is covered in depth on the deadlines page; the rules themselves are summarised in the table below.
| Device category | Registration obligation | Module entry |
|---|---|---|
| New Class I, IIa, IIb, III under MDR | Required on or before placing on the EU market from 28 May 2026 | UDI/Devices |
| New IVD class A, B, C, D under IVDR | Required on or before placing on the EU market from 28 May 2026 | UDI/Devices |
| Legacy MDR/IVDR devices on the market under Article 120 | Required by 28 November 2026 | UDI/Devices (narrowed legacy fields) |
| Custom-made devices under MDR Article 2(3) | Simplified record under MDR Article 21(2) | UDI/Devices |
| System and procedure packs under MDR Article 22 | Separate record per system or pack | UDI/Devices |
Who registers: manufacturer, authorised representative, importer
The legal entity placing the device on the EU market registers as an actor before any device record can be saved. MDR Article 31 sets the obligation for manufacturers, authorised representatives, and importers; MDR Article 11 governs the authorised-representative role; MDR Articles 13 and 14 govern importer and distributor obligations. Distributors do not register an actor record.
EU manufacturer flow
A manufacturer established in a Member State submits an actor request directly to its national competent authority through the EUDAMED Actor module. The competent authority verifies the registration details and issues a Single Registration Number (SRN). The SRN is the prerequisite for every downstream device record. The request route runs through the EC-hosted EUDAMED Actor module; the verification step is operated by the Member State authority.
Non-EU manufacturer flow (authorised representative required)
A manufacturer established outside the EU appoints an authorised representative established in a Member State under MDR Article 11. The authorised representative registers as an actor in EUDAMED and is verified by the competent authority of the Member State where it is established. The non-EU manufacturer registers separately as a manufacturer-actor and is linked to the authorised representative through the mandate record. Both actor records are needed before devices can be registered.
Importer and distributor obligations
An importer placing a device from a third-country manufacturer on the EU market registers as an actor under MDR Article 13. The importer’s SRN is recorded against device records the importer first places on the market. A distributor (downstream from the importer) does not register an actor record under MDR Article 14; its verification duties (CE marking, instructions for use, language compliance) sit outside EUDAMED. A distributor that also functions as importer for some device lines registers under the importer role for those lines.
| EU manufacturer flow | Non-EU manufacturer flow |
|---|---|
| 1. Manufacturer submits actor request to its national competent authority via the EUDAMED Actor module | 1. Non-EU manufacturer appoints an authorised representative in a Member State (MDR Art. 11) |
| 2. Competent authority verifies and issues SRN | 2. Authorised representative registers as an actor; competent authority verifies and issues SRN |
| 3. Manufacturer registers devices under its SRN | 3. Non-EU manufacturer registers as an actor (separate SRN); the mandate links it to the authorised representative |
| 4. Devices are registered under the non-EU manufacturer’s SRN with the authorised representative linked |
Member State competent authorities operate the verification step. The five named below are the most common; see references for full URLs.
The six EUDAMED modules in order
EUDAMED is a single database composed of six functional modules. The modules sit on different timelines and are operated by different parties. For a manufacturer registering devices, the practical sequence is Actor first, UDI/Devices second; the other four modules sit either upstream of the device record (Notified Bodies, where the certificate is recorded) or downstream (Vigilance, Market Surveillance, Clinical Investigations and Performance Studies).
| Module | Who operates it | Mandatory since | Manufacturer touchpoint |
|---|---|---|---|
| Actor registration | Manufacturer, authorised representative, importer; verified by Member State competent authority | 28 May 2026 (mandatory phase) | Yes (entry point, prerequisite for everything else) |
| UDI / Devices | Manufacturer (or authorised representative on the manufacturer’s behalf) | 28 May 2026 (new devices); 28 November 2026 (legacy devices) | Yes (the device record itself) |
| Notified Bodies and Certificates | Notified bodies | 28 May 2026 (mandatory phase) | Indirect (certificate linked to device record) |
| Clinical Investigations and Performance Studies | Manufacturer / sponsor | Phased; later timeline under Implementing Regulation (EU) 2024/1860 | Conditional (applies to devices requiring clinical investigation) |
| Vigilance | Manufacturer | Earlier mandatory phase (2024) | Yes (post-market) |
| Market Surveillance | Member State competent authorities | Earlier mandatory phase (2024) | No (authority-facing) |
The EC EUDAMED user guide for actors documents the sequence and the validation gates between modules. MDCG documents covering the actor and device modules (named in the references) set out the procedural guidance the Member States are coordinating against.
The four identifiers used in EUDAMED registration
A device record carries four distinct identifiers, each doing a different job. The identifiers chain together: Basic UDI-DI sits above UDI-DI, which sits above UDI-PI; EUDAMED-DI is a substitution path for legacy devices that never received a Basic UDI-DI under the directive regime. The assignment rules are set by MDR Article 27 read with MDCG 2018-1 Rev. 4 and the EC list of designated UDI issuing entities (GS1, HIBCC, ICCBBA, IFA).
| Identifier | What it identifies | Who assigns it | When assigned | Mandatory under | EUDAMED-DI substitution applies |
|---|---|---|---|---|---|
| Basic UDI-DI | Device model family (the regulatory entity) | Manufacturer, via a designated issuing entity | Before placing on EU market | MDR Art. 27; MDCG 2018-1 Rev. 4 | n/a (Basic UDI-DI is the primary key) |
| UDI-DI | Specific commercial configuration (per package level) | Manufacturer, via a designated issuing entity | At device packaging stage | MDR Art. 27 | n/a |
| UDI-PI | Production unit (lot, serial, expiry, manufacture date) | Manufacturer, applied at production | At manufacture | MDR Art. 27 | n/a |
| EUDAMED-DI | Legacy-device identifier where no Basic UDI-DI was assigned under MDD/AIMDD/IVDD | Manufacturer, generated against EC rules | At legacy registration | Implementing Reg. (EU) 2024/1860; Commission Decision (EU) 2025/2371 | Substitutes for Basic UDI-DI in the legacy record |
The assignment sequence is fixed: a Basic UDI-DI is assigned to the device family, then one or more UDI-DI records sit beneath it for each package level the manufacturer ships. UDI-PI is applied at production and recorded against the UDI-DI. For legacy devices on the EU market under Article 120 of the MDR, Commission Decision (EU) 2025/2371 allows a EUDAMED-DI to stand in for the Basic UDI-DI where the device was never assigned one. Dedicated guides cover Basic UDI-DI assignment and the four-identifier hierarchy in depth.
Picking the EMDN code for each device
EMDN is the European Medical Device Nomenclature, the EC-published code list every EUDAMED device record must carry. EMDN sits outside the UDI hierarchy and is assigned per device record at registration time. The nomenclature is a seven-level alphanumeric tree of around 8,500 codes hosted on the Commission’s EMDN portal and refreshed on an annual cadence following the procedure described in the MDCG guidance on EMDN updates.
The assignment rule from the EMDN portal is unambiguous: a device is coded to the most granular and terminal term available, never to a higher level when a lower level applies. Each alphanumeric code begins with a letter for the category, two digits for the group, and further digits to the granular type. EMDN coexists with the older GMDN (Global Medical Device Nomenclature) for some manufacturer internal systems; EUDAMED requires the EMDN code, not GMDN.
The practical work is matching the device-class language used in IFUs, labels, and internal product catalogues against the EMDN terminology. EMDN code selection is covered in its own dedicated guide; the assignment cadence and the annual update procedure are documented on the EC EMDN portal.
Deadlines: 28 May 2026 and 28 November 2026
Two deadlines bind manufacturers under the current regime. 28 May 2026 was the cutoff for new-device registrations under MDR Article 29, read with Article 123 transitional provisions and Implementing Regulation (EU) 2024/1860. Devices placed on the EU market on or after that date must be registered in EUDAMED before placement. 28 November 2026 is the deadline for legacy devices already on the EU market under MDR Article 120 transitional provisions to be added to EUDAMED, under the same Implementing Regulation. Commission Decision (EU) 2025/2371 narrows the field set required for legacy entries.
Three timing layers sit beneath the two regulatory dates. The regulatory deadline itself is fixed by the regulation. The manufacturer’s internal preparation timeline runs weeks to months, depending on portfolio size and source-document quality. EC processing time post-submission is typically immediate for non-NB-routed devices, and longer where a notified-body certificate record has to clear before the device record can be linked.
The 28 May 2026 and 28 November 2026 registration deadlines page covers the retrospective treatment, the directive-to-MDR legacy split, and the published date strings in detail.
PRRC sign-off in EUDAMED submissions
A manufacturer must have a designated Person Responsible for Regulatory Compliance (PRRC) under MDR Article 15. The PRRC’s role on EUDAMED submissions is to ensure that the technical documentation and the data submitted to EUDAMED comply with the regulation and the manufacturer’s quality management system. The qualification criteria for the PRRC are set out in MDR Article 15(1) and clarified in MDCG 2019-7. The manufacturer of record retains overall regulatory responsibility under MDR Article 10.
In an SME manufacturer arrangement, the PRRC role is often held internally by a senior regulatory affairs staff member. In arrangements with an external consultancy, the consultant principal is sometimes designated PRRC under contract. The contractual designation does not transfer the manufacturer’s regulatory responsibility, only the named compliance role.
The implication for preparation workflow is direct: every EUDAMED record passes through a documented PRRC review before the manufacturer authorises submission. A preparation tool that generates EUDAMED-schema-valid XML produces the file the PRRC reviews; the PRRC sign-off remains a human review step under MDR Article 15. EUDAPrep produces validated XML and the manufacturer (or the manufacturer’s PRRC) uploads it through the EC portal. The architecture is human-in-the-loop by construction: the tool does not transmit to EUDAMED on the user’s behalf.
Submission methods: EC user interface, XML bulk upload, and M2M
Three operational routes carry device data into EUDAMED. The EC user interface (web form) is the default route for small portfolios. XML bulk upload accepts schema-valid XML files prepared offline and uploaded through the portal. Machine-to-machine submission via AS4 / eDelivery is the future-state route for large enterprises; it requires EC onboarding, mutual TLS, and XAdES-signed payloads, and is not yet in scope for most manufacturers.
The XML route runs against the latest published EUDAMED XSD pack and the EC-published business-rule set. The EUDAMED Playground (webgate.training.ec.europa.eu) is the EC’s test environment for validating files before production submission. The XSD pack and the data dictionary are published in the EC Information Centre alongside the user guide for XML bulk upload.
| Method | Portfolio size fit | Engineering investment | Typical user | What the user prepares | What EUDAMED returns |
|---|---|---|---|---|---|
| EC user interface (web form) | 1 to ~20 devices | None | Small manufacturer, one-off legacy entry | Field-by-field entry through the EUDAMED UI | Per-field validation on submit |
| XML bulk upload | ~20 to several thousand devices | Low (schema-valid XML preparation) | SME manufacturer, RA consultant with multiple clients | EC-schema-valid XML file (per the published XSD pack) | XSD validation result and business-rule report; record IDs on accept |
| Machine-to-machine (AS4 / eDelivery) | Large enterprise with continuous registration flow | High (AS4 onboarding, mutual TLS, XAdES signatures) | Enterprise manufacturer, NB integration | Signed AS4 payload over the EC’s eDelivery transport | Acknowledgement message; record IDs on accept |
After submission, manufacturers verify their registration through the EUDAMED public search interface for records that are public-facing, and through the authenticated UI (“My Devices”) for non-public records. Legacy-device records and new-device records become public-searchable on different cadences; the EC’s eudamed-help documentation describes the current state. The submission methods comparison page covers the engineering trade-offs in depth.
Read next
- The 28 May 2026 and 28 November 2026 registration deadlines. Which devices fall into which deadline, the legacy treatment, and the retrospective date strings.
- EUDAMED submission methods compared. User interface, XML bulk upload and machine-to-machine: which fits a given portfolio.
- PRRC sign-off in EUDAMED submissions. Article 15 in operational terms: who signs, who carries the responsibility, what the contractual designation does and does not transfer.