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  1. Modification Description for SM

    Form | 07-02-2024

  2. Template cover letter SM

    Letter | 07-02-2024

  3. D2. IMDD-IVD template

    Form | 15-09-2023

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

    Form | 17-08-2023

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

    Form | 17-08-2023

  6. Instruction sheet for Site Suitability Declaration (VGO)

    Publication | 23-02-2023

  7. 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

  8. General terms and conditions Rates CCMO

    Publication | 20-10-2022

  9. EU template Declaration of interest investigator

    Publication | 07-09-2022

  10. EU template Declaration of interest investigator

    Publication | 07-09-2022