EUDAMED is no longer a future project. Since 28 May 2026, medical device manufacturers that sell in the EU must use it for key regulatory tasks. Devices already on the market must be registered by the end of November 2026.
This guide explains the EUDAMED requirements for medical device manufacturers in plain terms. You will learn what each module does, what data you must enter, and which dates matter. A checklist at the end helps you plan.
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What Is EUDAMED?
EUDAMED is the European Database on Medical Devices. It is the central EUDAMED medical device database for the EU. The European Commission built it to support the Medical Devices Regulation (MDR, EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR, EU 2017/746).
It has three main goals:
- Transparency: give the public clear information on devices sold in the EU.
- Traceability: link each device to its maker, certificate, and unique identifier.
- Oversight: let regulators in every EU country see the same data at the same time.
Why EUDAMED Is Now Mandatory
EUDAMED was built in parts. Regulation (EU) 2024/1860 allowed a gradual rollout. Each module becomes mandatory once the Commission confirms it works and publishes a notice in the Official Journal.
The notice, Commission Decision (EU) 2025/2371, came on 27 November 2025 and covered four of the six modules. Mandatory use began six months later, on 28May 2026.
In practice, a new device cannot be placed on the EU market unless its data is in EUDAMED.
The EUDAMED Six Modules Explained
The EUDAMED six modules cover the full life of a device. Four are mandatory now. Two are still in development.
The last two modules have no voluntary period. Until the Commission declares them ready, keep using national processes for vigilance reports and clinical study submissions.
EUDAMED Requirements for Medical Device Manufacturers
Manufacturers have two main jobs today: register as an actor, then register devices.
1. Actor Registration
Every manufacturer must register in the Actor module and receive an SRN. The module has been open for voluntary use since December 2020, so many manufacturers already hold an SRN. If you do, check that it is current. You need the SRN to complete EUDAMED device registration. For a new request, the EUDAMED registration process works like this:
- Create an EU Login account.
- Request access to EUDAMED for your organisation.
- Enter your company details, including legal name, address, and a contact person.
- Submit the request for review by the competent authority of your Member State.
- Receive your SRN once the request is validated.
Non-EU manufacturers must appoint an authorised representative. The representative also registers as an actor and confirms the mandate in EUDAMED. The competent authority of the representative's Member State validates the request and issues the SRN. Importers must register too.
Check every detail before you submit, because errors can delay validation. Actor data also needs upkeep under MDR Article 31(5). Update changes within one week, and confirm that your data is accurate within one year of submission and every two years after that.
2. UDI and Device Registration
The EUDAMED device registration module links each device to its Unique Device Identifier (UDI). Since 28 May 2026, you must register a new device before you place it on the EU market. Two identifiers matter here:
- Basic UDI-DI: groups devices that share the same intended purpose, risk class, and design features. It appears on certificates, the declaration of conformity, and the technical documentation, not on the label. For devices that need a notified body, assign it before you apply (MDR Article 29).
- UDI-DI: identifies a specific device version or package. It appears on the label together with the production identifier.
The EUDAMED UDI requirements also cover the data you submit. Typical data includes:
- Basic UDI-DI, UDI-DI, and your manufacturer SRN
- Trade name and model or reference
- Risk class and applicable regulation (MDR or IVDR)
- EMDN code (device nomenclature)
- Flags such as sterile, single-use, reusable, or implantable
- Certificate details from the notified body, where they apply
- Member States where the device is or will be made available
- UDI-PI type, such as batch or serial number
- SSCP reference for Class III and implantable devices
Check Annex VI of the MDR or IVDR for the full list. The official EUDAMED Information Centre offers guidance. Keep your labels and EUDAMED records aligned.
UDI codes come from an issuing entity: GS1, HIBCC, ICCBBA,or IFA. Group variants under one Basic UDI-DI only when they meet the MDCG2018-1 criteria: the same intended purpose, risk class, and essential design and manufacturing features.
Registration is not a one-time upload. Some changes, such as a new trade name or model, need a new UDI-DI. Others, such asa new certificate, can be updated in the existing record. Check Annex VI Part C before changing device data. Keep one master record for each device.
3. Legacy Devices
Devices placed on the market before 28 May 2026, and still placed on the market after it, must be registered by the end of November 2026. This includes legacy devices (devices placed under the old directives) and MDR or IVDR devices that are not yet in EUDAMED. Some sources cite 27 November, so plan for the earlier date.
If a legacy device has no UDI-DI yet, EUDAMED can generate an EUDAMED-DI, which stands in for the Basic UDI-DI, and an EUDAMED-ID, which stands in for the UDI-DI.
Start with the devices you still sell. Some cases are treated differently:
- A legacy device does not need registration if its replacement MDR or IVDR device is already registered.
- Custom-made devices follow their own rules.
- Devices for clinical investigations or performance studies follow their own rules.
- Devices with no further units placed on the market after 28 May 2026 need no registration, unless a vigilance report requires it. Units already shipped to distributors do not count.
The EUDAMED dates are the same for the MDR and the IVDR. What differs for in vitro diagnostics is the IVDR transition period for placing legacy devices on the market.
4. Certificates and Notified Body Data
Notified bodies enter certificate data. For valid certificates issued before 28 May 2026, they have until late May 2027. They also upload the validated SSCP for Class III and implantable devices, which manufacturers write. Check that entries linked to your devices are correct.
5. Market Surveillance (What Regulators See)
National authorities use this module. You do not enterdata here, but regulators can see your actor and device records.
EUDAMED Compliance Timeline for 2026 and Beyond
These dates shape your plan:
The legacy device deadline is only weeks away.
What comes next: the Commission is still working toward declaring the vigilance module functional. Mandatory use would follow six months after notice. Once it is live, serious incident reports, field safety corrective actions, trend reports, and periodic safety update reports(PSURs) will move into EUDAMED. The timing is expected, not confirmed, so watch the Official Journal for the announcement.
Switzerland: EUDAMED does not cover Switzerland. It runs its own database, swissdamed, which became mandatory on 1July 2026.
How to Prepare for EUDAMED Registration
The EUDAMED registration requirements are mostly about data. Teams often face the same three problems:
- Scattered data: device details sit in ERP systems, PLM tools, and spreadsheets.
- Large catalogues: hundreds of variants make manual entry slow and error-prone.
- Unclear ownership: data quality sits between Regulatory Affairs, QA, and IT, with no clear lead.
Start with a data audit of your device list, labels, and certificates.
EUDAMED offers three ways to submit data. You can enter it by hand in the web interface, upload XML files in bulk, or exchange data directly between your systems and EUDAMED (machine-to-machine). Small catalogues can use the web interface. Larger portfolios often need bulk uploador system connections.
Many manufacturers get outside help here. Pace Wisdom Solutions supports teams with AI for medical device regulatory compliance, from data audits to system integration.
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EUDAMED Compliance Checklist
Use this list to track your progress:
- Confirm that your actor registration and SRN are active.
- List every device on the EU market and group them by Basic UDI-DI.
- Mark which devices are new and which are legacy.
- Check UDI-DI data against labels and certificates, and fix any gaps.
- Choose your submission method: web interface, XML bulk upload, or machine-to-machine.
- Identify devices with no further units placed on the market after 28 May 2026.
- Set a rule for which changes need a new UDI-DI and which need only an update.
- Non-EU manufacturers: confirm that your authorised representative has accepted the mandate.
- Assign one owner for data quality, such as Regulatory Affairs, with QA and IT in support.
- Finish all legacy device registrations before the end of November 2026.
Conclusion
EUDAMED is now part of daily regulatory work. Actor and device registration are mandatory today, legacy devices must follow by the end of November 2026, and two more modules are still to come.
Act now. Start with the devices you still sell, confirm your SRN, and fix the data gaps that block registration. For large catalogues, use bulk upload or system-to-system submission. Then review your records after the deadline.
Need help with your legacy device backlog? Talk to the Pace Wisdom Solutions team.
Frequently Asked Questions
1. Is EUDAMED mandatory for medical device manufacturers?
Yes. Since 28 May 2026, the Actor, UDI/Device, Notified Bodies and Certificates, and Market Surveillance modules are mandatory. Manufacturers mainly use the first two, which cover actor registration and device registration.
2. What is the EUDAMED deadline for legacy devices?
Devices placed on the market before 28 May 2026, and still placed after it, must be registered by the end of November 2026. Some sources cite 27 November, so plan for the earlier date.
3. What is an SRN?
The Single Registration Number identifies your organisation in EUDAMED. You receive it after actor registration, and you need it to register devices.
4. Does EUDAMED apply to IVD manufacturers?
Yes. EUDAMED supports both the MDR and the IVDR, so in vitro diagnostic manufacturers must register too. The EUDAMED dates are the same for both. Only the IVDR transition period for placing legacy devices on the market differs.
5. Which EUDAMED modules are not mandatory yet?
The Vigilance and Post-Market Surveillance module and the Clinical Investigations and Performance Studies module. Use national processes for these until the Commission declares them functional.
6. Do non-EU manufacturers need to register?
Yes. They must meet the same requirements and appoint an authorised representative based in the EU.
7. How do I get access to EUDAMED?
Create an EU Login account first. Then request access for your organisation in the Actor module. The competent authority of your Member State reviews the request.
8. What happens if I miss the legacy deadline?
Registration is a legal obligation under the MDR and IVDR. Under MDR Article 113, each Member State sets its own penalties. Check guidance from your competent authority.
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