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  1. B1a. Eudamed-formulier

    Here you can download the latest version of the Eudamed form. Please use Appendix A to declare an additional IVD and Appendix B ...

    Form | 10-01-2023

  2. General terms and conditions Rates CCMO

    Publication | 20-10-2022

  3. EU template Declaration of interest investigator

    Publication | 07-09-2022

  4. EU template Declaration of interest investigator

    Publication | 07-09-2022

  5. Registration Eudravigilance

    Publication | 30-08-2022

  6. Overview of documents to be submitted for IVD performance studies

    Publication | 25-08-2022

  7. Flowchart Adverse events in IVD performance studies

    Publication | 12-08-2022

  8. E1/E2. Template Subject Information Sheet (English)

    Form | 15-07-2022

  9. E1/E2. Template Subject Information Sheet (Dutch)

    Form | 15-07-2022

  10. Standard research file Explanation

    Explanation of the standard research file and the explanation of codes and document titles for digital submission.

    Publication | 14-07-2022