EUDAMED becomes mandatory on May 28, 2026. Every manufacturer, authorized representative, and importer placing medical devices on the EU market must complete actor registration, assign UDIs, and upload device data before that date. Devices already on the market get a six-month grace period until November 28, 2026.
What is EUDAMED?
EUDAMED is the European Database on Medical Devices established under MDR Article 33. It serves as the central repository for device registrations, UDI data, certificates, clinical investigations, vigilance reports, and market surveillance information across all EU member states.
The mandatory use date of May 28, 2026 was triggered by Commission Decision (EU) 2025/2371, published November 27, 2025, which declared EUDAMED fully functional.
Who must register?
All economic operators in the medical device supply chain must register in EUDAMED:
| Actor | Obligation | MDR Article |
|---|---|---|
| Manufacturers | Actor registration + device registration + UDI | Article 31 |
| Authorized Representatives | Actor registration | Article 11 |
| Importers | Actor registration | Article 13 |
| System/procedure pack producers | Actor registration + device registration | Article 22 |
Non-EU manufacturers must register through their EU Authorized Representative.
Step 1: Complete actor registration and obtain an SRN
Every economic operator must register as an "actor" in EUDAMED and receive a Single Registration Number (SRN) before registering any devices.
The actor registration requires:
- Legal entity name, address, and contact details
- Role in the supply chain (manufacturer, AR, importer)
- Person Responsible for Regulatory Compliance (PRRC) details per MDR Article 15
- Competent authority validation (your national authority must verify the registration)
The competent authority review can take several weeks. Start immediately if you haven't already.
Step 2: Assign UDI-DIs to every device
Before registering devices, you must assign a Unique Device Identifier — Device Identifier (UDI-DI) to each device through an EU-recognized issuing entity (MDR Article 27 and Annex VI).
The four recognized issuing entities are:
- GS1 (gs1.org)
- HIBCC (hibcc.org)
- ICCBBA (iccbba.org)
- IFA (ifaffm.de)
Each UDI-DI must be unique to the device at the model/version level. If you already have UDI-DIs from a previous voluntary registration, verify they comply with the current format requirements.
Step 3: Register devices and upload UDI data
For each device, manufacturers must enter the following into EUDAMED (MDR Article 29):
- UDI-DI and any additional UDI-DIs (unit of use, configurable)
- Basic UDI-DI
- Device name and description
- Risk class and applicable classification rule
- Intended purpose
- Whether the device contains medicinal substances, tissues, or blood derivatives
- MRI compatibility information
- Active/implantable device status
- Critical warnings and contraindications
- Market status (on the market / no longer on the market)
- Notified Body identifier and certificate references
All data must be consistent with your technical documentation, labeling, and IFU. Inconsistencies between EUDAMED data and Notified Body certificates can trigger surveillance actions.
Step 4: Ensure certificate data alignment
Notified Bodies upload certificate data to EUDAMED independently. Your device registration data must match the certificates exactly — device name, classification, intended purpose, and scope.
If your Notified Body has not yet uploaded your certificates, contact them. Certificate registration is mandatory for the Notified Body under MDR Article 56.
Key deadlines
| Deadline | Requirement |
|---|---|
| May 28, 2026 | All economic operators must be registered (SRN). New devices cannot be placed on the market without EUDAMED registration. |
| May 28, 2026 | Actor registration, UDI/device registration, and certificate modules become mandatory. |
| November 28, 2026 | Legacy devices (placed on the market before May 28, 2026) must be registered. |
| May 28, 2027 | Clinical investigation and vigilance modules become mandatory. |
Common pitfalls
Data inconsistencies: EUDAMED data must match your technical documentation, labels, and NB certificates exactly. Mismatches in device name, classification, or intended purpose can delay registration and trigger competent authority queries.
Competent authority validation delays: Actor registration requires CA validation, which can take weeks. Do not wait until May to start.
Legacy device scope: All devices with a valid certificate — including those transitioning from MDD/AIMDD under the MDR transitional provisions — must be registered by November 28, 2026.
Multiple roles: If your organization acts as both manufacturer and importer for different products, you need to register both roles.
Key takeaways
- EUDAMED becomes mandatory May 28, 2026 — new devices cannot be placed on the EU market without registration
- Start with actor registration immediately — competent authority validation takes weeks
- Assign UDI-DIs through a recognized issuing entity before uploading device data
- Ensure all EUDAMED data matches your technical documentation, labels, and NB certificates
- Legacy devices already on the market must be registered by November 28, 2026
- Clinical investigation and vigilance modules follow in May 2027
How RegAid helps
RegAid covers the full text of EU MDR 2017/745 including all EUDAMED-related articles (29-34), UDI requirements (Article 27, Annex VI), and the Commission Implementing Regulations on EUDAMED. Ask "What data must manufacturers enter into EUDAMED for each device?" and get a cited answer with links to MDR Article 29 and Annex VI Part A.