Consulting Eudamed Registration

CMC Medical Devices offers EUDAMED Medical Device Registration

CMC supports manufacturers in obtaining EUDAMED registration for medical devices and IVD products in the European Union.

EUDAMED Registration

EUDAMED registration is mandatory from 28 May 2026, in accordance with EU Regulation 2017/745 (MDR) and 2017/746 (IVDR). This registration ensures that products comply with EU regulatory requirements, including the mandatory registration of UDI (Unique Device Identification) and device information, allowing them to be legally placed on the EU market.

CMC can manage EUDAMED registration either as your EU Authorized Representative (EU REP) or without being your EU REP, offering flexibility depending on your case and need.

Devices placed on the EU market before 28 May 2026 must be registered by 28 November 2026 under transitional provisions. With CMC’s expertise, you can ensure a smooth, compliant registration process and secure access to the EU market.

Our services include:

  • Preparation and submission of registration data to EUDAMED, including the Actor and UDI/Devices modules.
  • Acting as the local contact point for regulatory authorities if needed.
  • Assistance with updates, renewals, and communication with EUDAMED.
  • Support for UDI and device data submission in compliance with EUDAMED requirements.

Select CMC to validate your actor registration in EUDAMED

Complete the contact form and one of our consultants will get in touch as soon as possible.

    Frequently asked questions about EUDAMED registration

    Economic operators that must register in EUDAMED include:

    – Importers
    – Manufacturers from the EU and outside the EU
    – Producers of systems and procedure packs
    – Authorized representatives
    – In addition, Member States, notified bodies, and promoters must also input data into the database.

    Although registration in EUDAMED is not currently mandatory, manufacturers are strongly encouraged to register as actors and their devices. Some competent authorities are considering removing the national notification obligation for products registered in EUDAMED.

    Manufacturers must first register as an actor and then proceed to register the device. To register, manufacturers must:

    – Create an account and complete the required information.
    – Ensure that the devices comply with the applicable legislation (MDR/IVDR).
    – For manufacturers outside the EU, sign a mandate with the authorized representative.
    – Complete the actor registration and subsequently input the device information into the corresponding module, following the User Guide provided by the EU Commission.

    After completing the registration, the Authorized Representative must verify the UDI and device information registration in EUDAMED. The first registration is the actor registration, in which manufacturers must provide data about their company, such as address, information of the regulatory person, and company identification details. Subsequently, the Authorized Representative will validate the registration before the Competent Authority validates it. With this registration, manufacturers will receive the SRN number, which is required by notified bodies in the conformity assessment procedure.

    We facilitate the registration process in EUDAMED for manufacturers and their products

    Fast response

    We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

    Efficient communication

    Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

    Immediate support

    We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

    Quick resolution

    Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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