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FAQ

Found 4 questions and answers

  • Miscellaneous

    • Do manufacturers or EU authorised representatives have access to EUDAMED?
    • I am a Netherlands-based compiler, manufacturer, manufacturer’s authorised representative or importer. When does the law require me to complete registration in EUDAMED?
    • 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?
    • What is EUDAMED?

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