Simplify Your EUDAMED Registration
with a Trusted Partner
Legal background
Although not yet mandatory, EUDAMED registration offers a competitive and regulatory advantage. Failure to register once EUDAMED becomes fully functional could lead to serious compliance risks and delayed product access to the EU market.
Manufacturers who register early:
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- May be exempted from national notification requirements in some Member States.
- Gain access to SRN numbers, required by Notified Bodies for conformity assessment.
- Improve traceability and transparency in the supply chain.
- Stay ahead of regulatory deadlines by avoiding future bottlenecks when registration becomes mandatory.
Our services
Obelis EUDAMED Registration Services
We support both EU and non-EU manufacturers, importers, system and procedure pack producers, and other economic operators in successfully registering in EUDAMED. Our services include:
- Actor Registration: We help you register your organisation in EUDAMED and obtain your Single Registration Number (SRN).
- Device Registration: We guide you in uploading UDI/device data into the Device Module according to the EU Commission’s user guide.
- Mandate Management: For non-EU manufacturers, we act as your Authorised Representative and verify your registration.
- Document Preparation & Review: We ensure your submitted information complies with MDR/IVDR requirements.
- Fast-track validation: Thanks to our experience and location in Brussels, we facilitate faster communication and smoother validation with Competent Authorities.
With three modules already active, Actor Registration, UDI/Devices, and Notified Bodies and Certificates, early registration helps future-proof your compliance strategy.
FAQ
Frequently Asked Questions
EUDAMED is the European database established under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). It serves as a central platform to enhance transparency, traceability, and post-market surveillance of medical devices across the EU.
Manufacturers, authorised representatives, importers, system and procedure pack producers, and other economic operators involved in placing medical devices or IVDs on the EU market are responsible for registering their organisation and devices in EUDAMED.
As of now, registration in all EUDAMED modules is still voluntary but strongly recommended. Registration in each module will become mandatory after a certain transition period after it is announced by the European Commission that the respective module is fully functional.
Obelis supports EU and non-EU manufacturers and other economic operators by managing actor registration, obtaining Single Registration Numbers (SRN), uploading device data, and ensuring full compliance with MDR and IVDR requirements. Our Brussels location and regulatory expertise help fast-track validation and smooth communication with Competent Authorities.
