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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 fees 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. A1. Template cover letter amendment for the competent authority

    Letter | 14-07-2022

  9. Standard research file M1. Template progress report

    Publication | 29-06-2022

  10. Statement on compliance with Regulation (EU) 2016/679

    Publication | 31-05-2022

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