EUDAMED Registration

EUDAMED Registration for Non-EU Manufacturers

If your company is based outside the EU, you can’t register in EUDAMED without an EU Authorized Representative (EU-REP). Your EU-REP has to confirm the mandate before the competent authority issues your Single Registration Number (SRN). MedNet EC-REP GmbH, based in Münster, Germany, fulfills this role for more than 700 manufacturers.

  • Mandatory since 28 May 2026
  • Mandate confirmation for your Actor Registration
  • One contact for the EU, UK and Switzerland
  • EU-REP since 1990
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Two regulatory experts reviewing a step-by-step online eudamed registration form on a touchscreen in a bright office

In Brief

  • Since 28 May 2026, Actor Registration and UDI/Device Registration in EUDAMED have been mandatory.
  • Non-EU manufacturers need an EU-REP to confirm their mandate before the competent authority issues an SRN.
  • Actor and device registration are the manufacturer’s obligation (Articles 29 and 31 MDR / Articles 26 and 28 IVDR).
  • Medical devices and IVDs placed on the market before 28 May 2026, including legacy devices, must be registered by 28 November 2026 if they continue to be placed on the market.
  • A company acting in several roles, such as manufacturer, importer or system and procedure pack producer (SPPP), needs a separate SRN for each role.

What Applies in EUDAMED Since 28 May 2026

Since 28 May 2026, four EUDAMED modules have been mandatory: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance. The legal basis is Commission Decision (EU) 2025/2371 of 26 November 2025. The Vigilance and Clinical Investigations/Performance Studies modules are not yet functional.

Manufacturers have to work actively in two of these modules: Actor Registration and UDI/Device Registration. Notified Bodies and Certificates is maintained by the notified bodies, Market Surveillance by the competent authorities.

Actor Registration gives you your SRN. It also holds your company address and the details of your Person Responsible for Regulatory Compliance (PRRC), which you need to keep up to date. Only with an SRN can you register your devices, which means submitting the Basic UDI-DI, the UDI-DI (Unique Device Identifier) and the related device data.

Both registrations are the manufacturer’s obligation. A non-EU manufacturer, however, can’t complete Actor Registration until its EU-REP has confirmed the mandate in EUDAMED.

What MedNet EC-REP Does as Your EU-REP

MedNet EC-REP GmbH is registered in EUDAMED as an Authorized Representative under the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). You can therefore select us directly in your Actor Registration request.

  • We send you a mandate summary template, already filled in with our details. You add your company data and device groups and upload it with your request.
  • Once the mandate is signed, we confirm your Actor Registration request in EUDAMED.
  • On request, we enter your device data for you, for example as a bulk upload for larger portfolios.
  • You have one contact for the EU, the UK and Switzerland.

Registration remains your obligation as the manufacturer, even if you commission us with the data entry. We represent manufacturers and don’t consult for them, so there’s no conflict of interest between the two roles.

How Registration Works

For a non-EU manufacturer with MedNet EC-REP as its EU-REP, EUDAMED registration runs in five steps:

  1. 1

    Appoint Your EU-REP

    You appoint MedNet EC-REP as your EU-REP and sign the mandate. We send you the mandate summary template to complete.

  2. 2

    Submit Your Request

    Create your Actor Registration request via EU Login, select MedNet EC-REP as your EU-REP and upload the mandate summary. Then let your MedNet contact know by email.

  3. 3

    We Confirm the Mandate

    We confirm your request in EUDAMED

  4. 4

    Authority Issues Your SRN

    The competent authority, for MedNet clients the Bezirksregierung Münster, reviews your request and issues your SRN. From then on, your EU Declaration of Conformity must state your SRN and ours.

  5. 5

    Register Your Devices

    With your SRN, you register your devices in the UDI/Device Registration module. Before you do, we need your complete technical documentation and certificates. On request, we can handle the data entry for you.

Key Deadlines

New medical devices and IVDs must be registered in EUDAMED before they are placed on the market. Medical devices and IVDs placed on the market before 28 May 2026, including legacy devices, have until 28 November 2026 if they continue to be placed on the market.

Devices

Deadline

New devices placed on the market from 28 May 2026

Registration before placing on the market

MDR or IVDR devices placed on the market before 28 May 2026 and still being placed on the market

28 November 2026

Legacy devices still being placed on the market

28 November 2026

Devices no longer placed on the market from 28 May 2026

No registration required, unless a vigilance case arises. The device must then be registered

Many manufacturers completed Actor Registration before the module became mandatory. If you don’t have an SRN yet, start there: you can’t register any devices without it, and queries from the authority about your master data can cost weeks before 28 November.

Common Registration Mistakes

Most delays in EUDAMED Actor Registration can be avoided. These three mistakes are easy to catch early:

  • The EU-REP is brought in too late. Without a confirmed mandate, the request stalls.
  • A company with several roles, such as manufacturer, importer or SPPP, assumes one SRN covers everything. Each role needs its own SRN.
  • Master data is inconsistent.

Your organization also needs at least one active Local Actor Administrator (LAA) at all times. The European Commission recommends appointing at least two. If your only LAA leaves the company, access has to be restored through EUDAMED support, and until then you can’t update your actor data or register devices.

We cover all five common mistakes and how to avoid them in our article:

→ The Most Common Mistakes in Initial EUDAMED Actor Registration

Already Working With an EU-REP?

Only a manufacturer’s own EU-REP can confirm its mandate in EUDAMED. If you’d like to switch to us, check the notice period in your current mandate first. Your SRN stays the same; only the EU-REP in your Actor Registration is updated.

If you would like to change your EU Authorized Representative, please feel free to contact us.

For UK PARD, Swissdamed and national databases, see Product Registration.

EUDAMED Registration - Frequently Asked Questions

Here are the questions we hear most often from manufacturers preparing for EUDAMED registration.

Need an EU-REP for Your EUDAMED Registration?

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Sources

Reviewed by the MedNet EC-REP Regulatory Affairs team · Last updated: 12.10.2026