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EUDAMED Update Alert: v2.18.1 is now live!
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The European Commission has deployed EUDAMED v2.18.1 on Dec 17, 2025. Key takeaway: No changes to XSD schemas, the version remains 3.0.22.1. For full release notes and documentation, check out the Information Centre |
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The Implementing Act has been officially published in the Official Journal as of 27 November 2025
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Important Deadlines for Medical Device Manufacturers:
The following EUDAMED modules are now active:
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16 Oct 2025 Updates to Actor Registration (EUDAMED v2.18.0, 2025)
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The 16 October 2025 EUDAMED release (v2.18.0, 2025) introduces refinements to the Actor Registration Module which impacts manufacturers, authorized representatives, and importers. These updates aim to improve data accuracy and communication with Competent Authorities, while also resolving common usability issues Key updates include:
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The Implementing Act has been officially published in the Official Journal as of 27 November 2025
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Important Deadlines for Medical Device Manufacturers:
The following EUDAMED modules are now active:
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WHAT IS THE ACTOR REGISTRATION MODULE: WHY THIS MATTERS TO YOU?
The Actor Registration Module is the first active part of EUDAMED. It’s where economic operators (companies involved in making, importing, or distributing medical devices) register themselves before doing anything else in the system.
Once registered, each company receives a Single Registration Number (SRN) – a unique EU-wide ID number for all future regulatory processes.
If you’re a manufacturer (especially outside the EU), registering in this module is your first official step toward EU compliance
Note : The Actor Registration Module is just one part of EUDAMED, but it’s the foundation for everything else. Without completing Module 1, you cannot access the others.
WHO COUNTS AS AN “ACTOR”?
You’re considered an actor in EUDAMED if you are:
- EU manufacturer
- Non-EU manufacturer (also known as “third country”)
- Authorized Representative (AR) (for non-EU manufacturers)
- EU Importer
- System or Procedure Pack Producer
All of these parties must register in the Actor Module and be approved by their national competent authority (NCA) before placing any devices on the EU market.
WHY ACTOR REGISTRATION IS CRUCIAL
It’s Legally Required
- You cannot submit device data, certificates, or safety reports in EUDAMED without registering as an actor first.
It Prevents Delays in Market Access
- Regulators, importers, and partners will require your SRN. Without it, your product launch or CE marking process could stall.
It Connects You to Other EUDAMED Modules
Once you’re registered, you can access other modules like:
- UDI/Device
- Certificates
- Vigilance
- Clinical Investigation
It Enables Transparency and Trust
- The EU uses your Actor Registration to verify your role, identity, and responsibilities. It helps create a safe, monitored, and traceable medical device ecosystem.
WHAT YOU NEED TO REGISTER
Here’s what you need to do:
Company Information
- Name, legal entity, address
- Role (manufacturer, AR, importer, etc.)
Authorised Representative Mandate- (Only for non-EU manufacturers)
- Signed document proving legal appointment of your AR
Information Security Declaration
- A signed form acknowledging your company’s data security responsibilities
Proof of Business Existence
- Business registration certificate or similar document
EUDAMED User Account
- You must set up an account to submit your request
STEP-BY-STEP: HOW ACTOR REGISTRATION WORKS
| STEP | WHAT HAPPENS |
| 1 | You create an account in EUDAMED |
| 2 | You fill out the Actor Registration form |
| 3 | You upload the necessary documents |
| 4 | You submit the application to your national competent authority (NCA) |
| 5 | NCA reviews and either approves or rejects your request |
| 6 | Once approved, you receive your SRN (Single Registration Number) |
| 7 | You can now assign internal users and move to other modules |
Timeline? Approval usually takes a few days to weeks, depending on the authority and completeness of your documents.
WHAT HAPPENS AFTER REGISTRATION?
Once your Actor Registration is approved, here’s what’s next:
- Get access to the rest of EUDAMED
- Start registering devices
- Submit certificates & reports
- Assign internal users (with different roles)
If you’re a non-EU manufacturer, your Authorized Representative must also complete their own registration and accept their mandate before your profile is activated.
TIPS FOR A SMOOTH REGISTRATION
- Use the official EUDAMED portal: EUDAMED Actor Registration
- Download the document templates (security declaration, mandate form)
- Double-check your business registration and legal representative info
- Assign an internal team member to manage EUDAMED access
- Monitor email from your NCA for updates or corrections
CONCLUSION
The Actor Registration Module is more than a formality – it’s your company’s official gateway into the EU medical device market, as defined under the European Commission’s EUDAMED framework. Without a validated registration and a Single Registration Number (SRN), you simply won’t be able to access critical modules such as device registration, vigilance, or certificate uploads, all of which are essential to placing your products legally on the market in Europe (EC, 2023). Registration is handled via EUDAMED’s Actor module and reviewed by the national competent authority (NCA), with the SRN issued only upon approval (EUDAMED Helpdesk, 2023). This unique number becomes your digital identity across all EU countries — avoiding duplication and reinforcing transparency.
HOW WE CAN HELP
At Morulaa, helps medical device companies complete EUDAMED Actor Registration smoothly by guiding them through every step from identifying their correct actor role and preparing required documents to creating EUDAMED accounts and obtaining the Single Registration Number (SRN). The team assists with Authorized Representative mandates, liaises with National Competent Authorities (NCA), and ensures compliance with EU MDR/IVDR regulations. After registration, Morulaa supports clients in device registration, vigilance, and certificate submissions, ensuring full EU market readiness with minimal delays.