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EUDAMED Registration Service

Cert3Global provides professional EUDAMED Registration Service to help medical device manufacturers comply with EU MDR (EU 2017/745) and IVDR (EU 2017/746). We support you in completing actor registration, UDI submissions, and database compliance—ensuring your products are properly registered and ready for the European market.

Our structured approach ensures accuracy, reduces delays, and helps you meet evolving regulatory requirements with confidence.

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Expert EUDAMED Registration Support

EUDAMED (European Database on Medical Devices) is a central database introduced under EU MDR and IVDR to improve transparency, traceability, and regulatory oversight of medical devices in the European Union.

Manufacturers, authorized representatives, importers, and other economic operators are required to register in EUDAMED and submit relevant product and compliance information. This includes actor registration, device data, certificates, and vigilance-related information.

Cert3Global offers a structured EUDAMED Registration Service that helps you complete registrations accurately and efficiently. We guide you through each requirement, ensuring that your data is correctly submitted and aligned with EU regulations.

What is EUDAMED?

EUDAMED is the European database for medical devices, developed by the European Commission to centralize information related to devices, manufacturers, certificates, and post-market activities.
The database consists of multiple interconnected modules, including:
  • Actor registration
  • UDI/device registration
  • Notified Body and certificate information
  • Clinical investigations and performance studies
  • Vigilance and post-market surveillance
  • Market surveillance
EUDAMED enhances transparency and allows regulators, healthcare professionals, and, in some cases, the public to access key information about medical devices.

Why is EUDAMED Registration Important?

EUDAMED registration is a key requirement under EU MDR and IVDR. It ensures that all economic operators and devices are properly recorded within the EU regulatory system.
Accurate registration supports traceability, improves regulatory oversight, and ensures that your products can be monitored throughout their lifecycle.

Key Benefits

  • Ensures compliance with MDR and IVDR requirements
  • Improves product traceability through UDI systems
  • Enables transparency within the EU medical device market
  • Supports post-market surveillance and vigilance reporting
Using a professional EUDAMED Registration Service helps ensure that submissions are accurate and aligned with regulatory expectations.
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EUDAMED Registration Services

Cert3Global provides focused EUDAMED Registration Service to support accurate and compliant data submission under EU MDR and IVDR.

Actor Registration (SRN Application)

We assist manufacturers, authorized representatives, and importers in registering as economic operators and obtaining a Single Registration Number (SRN).

UDI & Device Registration

Support for submitting Unique Device Identification (UDI) data and registering devices within EUDAMED.

Data Entry & Validation

Ensure accurate data submission aligned with EUDAMED structure and regulatory requirements.

Notified Body & Certificate Data Support

Assist in linking certificates and Notified Body information within the database.

Ongoing Updates & Maintenance

Support for updating records, maintaining compliance, and managing changes over time.

EUDAMED Registration Process

The EUDAMED registration process involves several steps to ensure compliance with EU regulations:
  • Actor registration and SRN generation
  • Assignment of roles (manufacturer, AR, importer)
  • UDI and device data submission
  • Upload of certificates and relevant documentation
  • Validation and approval within EUDAMED modules
  • Ongoing updates and data maintenance
Each step must be completed accurately to ensure successful registration and avoid compliance issues.

Who Needs EUDAMED Registration?

EUDAMED registration is required for all economic operators involved in placing medical devices on the EU market.
This includes:
  • Manufacturers
  • EU Authorized Representatives
  • Importers
  • System and procedure pack producers

Non-EU manufacturers must work with an EU Authorized Representative to complete registration and maintain compliance.

Why Choose Cert3Global?

Cert3Global offers reliable and structured EUDAMED Registration Service designed to simplify complex regulatory requirements.
We provide:
  • End-to-end EUDAMED registration support
  • Expertise in MDR and IVDR compliance
  • Accurate data submission and validation
  • Guidance on UDI and SRN processes
  • Ongoing regulatory support
Our approach ensures that your registration is handled efficiently, reducing errors and ensuring compliance with EU regulations.

Start Your EUDAMED Registration!

EUDAMED registration is a critical step in achieving EU compliance for medical devices. Cert3Global provides expert support to ensure accurate submissions and smooth regulatory processes.
Book a Free 15-Minute Compliance Call!

FAQs

What is EUDAMED?
EUDAMED is the European database for medical devices that centralizes regulatory information under MDR and IVDR.
Yes, it is required for economic operators and device registration under EU regulations.
A Single Registration Number (SRN) is assigned to economic operators after successful registration in EUDAMED.
UDI (Unique Device Identification) is used to track and identify medical devices within the database.
Manufacturers, authorized representatives, importers, and other economic operators.

Disclaimer

Cert3Global provides regulatory consulting and support services. Registration outcomes, timelines, and market access remain subject to applicable UK regulations and MHRA processes.