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  1. E1/E2. Template Subject Information Sheet Children up to 12 Years of Age (English)

    Form | 17-08-2023

  2. E1/E2. Template Subject Information Sheet Children 12 - 16 Years of Age (English)

    Form | 17-08-2023

  3. Instruction sheet for Site Suitability Declaration (VGO)

    Publication | 23-02-2023

  4. 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

  5. General terms and conditions fees CCMO

    Publication | 20-10-2022

  6. EU template Declaration of interest investigator

    Publication | 07-09-2022

  7. EU template Declaration of interest investigator

    Publication | 07-09-2022

  8. Registration Eudravigilance

    Publication | 30-08-2022

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

    Publication | 25-08-2022

  10. Flowchart Adverse events in IVD performance studies

    Publication | 12-08-2022

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