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  1. Do manufacturers or EU authorised representatives have access to EUDAMED?

    Yes. There is a protected version in which economic operators register data centrally. There is also a public version of Eudamed ...

    Frequently asked questions

  2. What is EUDAMED?

    EUDAMED is the European database for medical devices that all EU Member States are required to use. This database contains ...

    Frequently asked questions

  3. I am a Netherlands-based manufacturer or this manufacturer’s authorised representative. If I choose to register an actor and product for Class I medical devices and IVD in EUDAMED, will I also be required to submit a notification via NOTIS in order to comply with national legislation?

    No. The government recognises information on Class I medical devices and IVD registered in the EUDAMED modules that have been ...

    Frequently asked questions

  4. I am a Netherlands-based compiler, manufacturer, manufacturer’s authorised representative or importer. When does the law require me to complete registration in EUDAMED?

    Once the European Commission announces that EUDAMED is fully operational, you will have another 6 months to register as an actor ...

    Frequently asked questions