EUDAMED Registration 2026: The Complete Guide for Medical Device Manufacturers

Reading time: approx. 15 minutes | Audience: Manufacturers, authorised representatives, importers of medical devices

At a Glance (TL;DR)

• From 28 May 2026, the first four EUDAMED modules are mandatory — no further delay.
• New devices must be registered in EUDAMED before being placed on the EU market.
• Legacy devices (already on the market before 28 May 2026) must be registered by 28 November 2026.
• Without an SRN (Single Registration Number), device registration is impossible — apply now, as processing takes 2–8 weeks.
• Modules 5 and 6 (Vigilance, Clinical Investigations) are not yet mandatory, but Module 5 is expected around Q3 2026.

What Is EUDAMED?

EUDAMED — the European Database on Medical Devices — is the EU's central database for medical devices and in vitro diagnostics. It was established under Article 33 of EU MDR (Regulation 2017/745) and Article 30 of EU IVDR (Regulation 2017/746).

The goal: greater transparency about medical devices on the EU market, improved market surveillance, and better patient safety. Through EUDAMED's public interface, regulators, hospitals and patients can check which devices are on the market, which certificates are valid, and whether any recalls have occurred.

EUDAMED replaces national databases — manufacturers no longer need to register separately in each Member State. One registration in EUDAMED is recognised across the entire EU.

Important for non-EU manufacturers: If your company is not established in the EU, you must appoint an Authorised Representative (AR) who will carry out EUDAMED registration on your behalf.

Legal Basis: Commission Decision (EU) 2025/2371

On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371 in the Official Journal of the EU, officially declaring the first four EUDAMED modules functional. Under the transitional provisions of Regulation (EU) 2024/1860, this started a six-month window, making use of the four modules mandatory from 28 May 2026.

Unlike the UK, which maintains its own MHRA registration system (DORS) independently, EU manufacturers must use EUDAMED as the single EU-wide registration system.

The 6 EUDAMED Modules Explained

EUDAMED is divided into six thematic modules, each covering a different aspect of product oversight.

Module 1: Actor Registration

The foundation of EUDAMED. All economic operators — manufacturers, authorised representatives, importers — register here and receive their SRN (Single Registration Number). Without an SRN, no device registration in the UDI module is possible.

Module 2: UDI/Device Registration

All medical devices are registered here using their Basic UDI-DI (the primary identifier of a device family) and all associated UDI-DIs (at the trade item level). The data requirements are set out in MDR Annex VI, Parts A and B.

Module 3: Notified Bodies & Certificates

Notified Bodies upload their issued certificates here. For manufacturers of Class IIa, IIb and III devices, this is indirectly relevant, as the notified body will verify EUDAMED entries during audits.

Module 4: Market Surveillance

Contains information on ongoing and completed market surveillance measures, recalls, and Field Safety Corrective Actions (FSCA).

Modules 5 & 6: Vigilance and Clinical Investigations

Both modules are still under development. Until they are officially activated, national reporting routes continue to apply. Importantly, Modules 5 and 6 have no voluntary use period — they become mandatory immediately upon activation.

Deadlines: What Applies When?

EUDAMED deadlines are legally fixed. There are no further extensions.

NOV 2025  ──▶  Decision (EU) 2025/2371 published
               Modules 1–4 officially declared functional

MAY 2026  ──▶  28 May 2026: MANDATORY START Modules 1–4
               • New devices must be registered before market placement
               • Actor registration with SRN required
               • Without EUDAMED entry: no legal EU market access

NOV 2026  ──▶  28 November 2026: DEADLINE legacy devices
               • All devices placed on the market before May 2026
               • MDR devices with MDD certificates (transitional periods)

MAY 2027  ──▶  28 May 2027: DEADLINE certificates
               • Notified Bodies must have uploaded all certificates
                 issued before May 2026 into Module 3

2026/27   ──▶  Modules 5–6: date still open
               • No voluntary use period
               • Vigilance module expected approx. Q3 2026

Step-by-Step: How to Register in EUDAMED

Step 1: Create an EU Login Account

EUDAMED uses the European Commission's central authentication system. Before you can do anything in EUDAMED, you need an EU Login account.

How to do it:

1. Go to https://webgate.ec.europa.eu/cas/
2. Click "Create an account"
3. Enter a business email address (avoid personal email addresses)
4. Confirm the email address
5. Log in to EUDAMED for the first time: https://ec.europa.eu/tools/eudamed/

Tip: Set up at least two EU Login accounts for your company (LAA and backup LAA). The UDI module will not be activated until two Local Actor Administrators (LAA) are registered in the system.

Step 2: Actor Registration — Apply for Your SRN

The actor registration is the first and most important step. You will receive your SRN (Single Registration Number) — an EU-wide unique identifier in the format CC-TT-NNNNNNNNN (e.g., DE-MF-123456789).

Actor Registration process:

1. In EUDAMED go to "Actor Registration" → "New Registration Request"
2. Select your role: Manufacturer, Authorised Representative, Importer, or System/Procedure Pack Producer
3. Enter company information:
   • Official company name (as in the commercial register)
   • Legal form
   • Full address and country
   • EORI number (if available)
   • Contact details of the responsible person
4. Upload declaration: A standardised declaration confirming data accuracy
5. Submit the application — it goes directly to your national competent authority
6. Wait for approval: Processing typically takes 2–8 weeks, depending on the Member State.

⚠️ Critical: Start the Actor Registration now, not just before the deadline. If your SRN has not been issued by 28 May 2026, you cannot legally place new products on the EU market.

Step 3: Assign a Basic UDI-DI

Before registering a product in EUDAMED, you need a Basic UDI-DI (Basic Unique Device Identification — Device Identifier). The Basic UDI-DI is the main identifier of a device family (same intended purpose, same design, same manufacturing processes).

EU-approved UDI Issuing Agencies:

Step 4: Register Your Device in the UDI/Device Module

Once you have your SRN and Basic UDI-DI, register your product in EUDAMED's UDI/Device module. Required data is set out in MDR Annex VI, Part A (core data elements for all products) and Part B (additional data for implantable and Class III products).

Key mandatory fields include:

• Basic UDI-DI and all associated UDI-DIs
• Trade name(s) of the device
• Product description and intended purpose
• Risk class (I, IIa, IIb, III)
• Certificate number and notified body (if applicable)
• EMDN code (European Medical Device Nomenclature)
• Sterility, reuse information
• Clinical sizes/variants

Step 5: Ongoing Obligations

EUDAMED is not a one-time registration. As a manufacturer, you have ongoing obligations:

• Report changes: Any change to registered data must be updated in EUDAMED within one week
• Supply interruptions: Temporary supply interruptions or market withdrawals must be reported under Article 10a MDR
• Product discontinuations: Permanent market withdrawals must be recorded in EUDAMED
• Annual updates: Certain information (e.g., sales figures for implantable devices) must be updated annually

Who Must Register? Obligations by Role

Special Considerations for Software as a Medical Device (SaMD)

Yes, EUDAMED applies to pure software classified as a medical device (Software as a Medical Device, SaMD).

What this means in practice:

• UDI requirements for SaMD: Each software version that has a new intended purpose or significant design change requires a new Basic UDI-DI. Patches and minor updates without clinical relevance can retain the same Basic UDI-DI.
• Version management: The current software version must be stated in EUDAMED. The registration must be updated with each significant release.
• Risk class: SaMD can be Class I to III — this determines the scope of EUDAMED entries.

Refer to MDCG 2019-16 (Rev. 1) for guidance on UDI for software.

Consequences of Non-Compliance

• Market access prohibition: Devices not correctly registered in EUDAMED cannot be placed on the EU market from 28 May 2026.
• Dual liability (Article 10a MDR): For unreported supply interruptions, manufacturers and, in some cases, authorised representatives may be held liable for damages caused by product unavailability.
• Notified body audits: Notified bodies verify EUDAMED entries against technical documentation during audits. Discrepancies can lead to suspension or withdrawal of certificates.
• Market surveillance authorities: National competent authorities can impose fines and initiate market surveillance measures for incorrect or missing entries.

Frequently Asked Questions (FAQ)

My device is still certified under MDD. Do I still need to register in EUDAMED?

Yes. The EUDAMED registration obligation applies to all products on the EU market from 28 May 2026, regardless of whether they are certified under MDD or MDR. For MDD devices still permitted under MDR transitional provisions, the catch-up deadline is 28 November 2026.

How long does SRN issuance take?

It depends on the national competent authority. Processing typically takes 2–8 weeks. Some authorities process applications within 2–3 working days; others take longer. Plan at least 8 weeks lead time.

Do I need an authorised representative for EUDAMED?

Only if your company has no establishment in the EU. EU manufacturers register directly. Non-EU manufacturers must appoint an Authorised Representative who will handle the registration.

What does EUDAMED registration cost?

Using EUDAMED itself is free. Indirect costs arise from: UDI Issuing Agency fees (GS1 membership, HIBCC licence), potential consultancy costs, and internal effort for data preparation (Annex VI data).

Can I register multiple products at once?

Yes. EUDAMED offers a bulk upload function via XML files — the most efficient method for manufacturers with large product portfolios.

Does EUDAMED apply to products sold only in one EU country?

Yes. EUDAMED is an EU-wide obligation, regardless of how many Member States you sell in.

EUDAMED Readiness Checklist

Preparation

• EU Login account created (min. 2 people registered as LAA)
• National competent authority identified
• Own role(s) in EUDAMED defined (manufacturer, AR, importer)

Actor Registration

• Actor Registration in EUDAMED completed
• SRN received and documented
• Backup LAA set up (prerequisite for UDI module)

UDI & Device Registration

• UDI Issuing Agency selected and membership/licence applied for
• Basic UDI-DI assigned for all device families
• MDR Annex VI data (Parts A + B) prepared for all products
• Devices registered (or prepared for registration) in UDI/Device module
• Legacy devices identified and catch-up registration planned (deadline: 28 Nov 2026)

Ongoing Processes

• Internal process for EUDAMED updates established (changes < 1 week)
• Internal responsibility for EUDAMED maintenance assigned
• Team trained (RA manager, regulatory affairs, quality manager)

Sources and Further Reading

• European Commission, EUDAMED portal: https://ec.europa.eu/tools/eudamed/
• Commission Decision (EU) 2025/2371 — Official Journal of the EU, 27 November 2025
• EU MDR 2017/745 full text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
• Regulation (EU) 2024/1860 (transitional provisions): EUR-Lex
• MDCG 2019-5: Legacy Devices Registration in EUDAMED
• MDCG 2019-16 Rev. 1: UDI for software
• EU Login: https://webgate.ec.europa.eu/cas/