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EUDAMED Registration Services for MDR & IVDR Compliance

Ensure seamless EUDAMED registration and compliance with expert support for Actor and UDI registration under MDR and IVDR.

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EUDAMED Registration Requirements and Timeline for Manufacturers

EUDAMED is a database of information about medical devices, IVDs, and the organizations involved in the European device market. Registration in EUDAMED is a new requirement under the European Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Devices Regulation (IVDR 2017/746).

With the publication of the Implementing Decision published on 27 November 2025, the formal transition toward mandatory EUDAMED usage has commenced.

The regulatory timelines are as follows:

  • 27 November 2025 – Publication of Commission Implementing Decision (EU) 2025/2371 confirming system functionality
  • 28 May 2026 – Mandatory use of the four validated EUDAMED modules begins, following the six-month transition period
  • Q2 2027 – Mandatory use of the Vigilance module anticipated, subject to successful audit completion and the publication of a separate notice

What does the EUDAMED roll out mean for manufacturers?

Actor registration

Manufacturers must register their company as an Actor in EUDAMED. Actor registrations must be completed before you can begin registering UDIs. Your Competent Authority or Notified Body must review and approve your Actor registration before it becomes live. The timeline for Actor approvals can vary considerably between CAs and NBs. As the mandatory due date approaches, bottlenecks and delays for Actor registration reviews are inevitable. Plan to complete your registration well in advance of the mandatory due date to avoid a delay that could cause you to be out of compliance. 

Device/UDI registration

Once your Actor registration is live, you can register your devices using the Device/UDI registration module. UDI registrations do not require review and approval. However, completing your registrations could be time consuming, especially if you have a large portfolio of devices/UDIs. You will need to acquire UDI and European Medical Device Nomenclature (EMDN) codes for each device, as well as have all the requisite device details and characteristics on hand to complete the registrations.  

If your UDI system is not already in EUDAMED, our experienced team can manage all aspects of UDI implementation.

Maintain EUDAMED registrations

If you have already completed your Actor and UDI registrations, whether to comply with specific NB or CA requirements, or on a voluntary basis, you are well on your way to being ready for the EUDAMED roll out. But EUDAMED registration isn’t a one-time obligation. You must keep your registrations up to date and register new UDIs when relevant device changes occur. The EUDAMED interface and its data requirements will continue to evolve, and you will need to stay informed about changes that affect your registrations.

EUDAMED registration is simple with MedEnvoy

MedEnvoy can help you transition to mandatory EUDAMED registration and reporting with minimal disruption to your resources and business operations. With our combination of regulatory expertise and technical solutions, we can manage your initial Actor and UDI registrations and maintain them over the lifecycle of your devices.

How we can help:

Outsource a tedious registration process

Our team has deep expertise in conducting registrations and in-depth knowledge of EUDAMED’s interface and data requirements. We will ensure all device information is accurately uploaded to EUDAMED, with support from our custom cloud-based platform, GloRIAS. We will register your company as a legal manufacturer, manage registration of all your devices at the UDI-DI level, and assist with obtaining your Single Registration Number (SRN).

Streamline data management

MedEnvoy’s in-country representative (European Authorized Representation (EAR), UK Responsible Person (UKRP), Swiss Authorized Representative (CH REP)) and/or Regulatory Importer customers can provide one set of data and documentation that supports all their services. This allows us to offer these customers discounted fees on our EUDAMED Registration Management service.

Leverage our custom tool, GloRIAS

We designed and built our cloud-based solution, GloRIAS, to simplify EUDAMED registration and support ongoing EUDAMED updates and new device registrations. GloRIAS provides efficient data transfer and document sharing required for EUDAMED device registrations and updates. Your dedicated account manager will work with you to ensure your device registration information in GloRIAS is complete and up-to-date, so we can seamlessly maintain your EUDAMED registrations.

Access our regulatory experts

Our experienced Regulatory Affairs team will be available to you for any questions and regular updates on regulatory developments. You will also have access to our regulatory resources and newsletter, so you can stay informed about industry changes that affect your registrations.