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  1. EU template Declaration of interest investigator

    Publication | 07-09-2022

  2. EU template Declaration of interest investigator

    Publication | 07-09-2022

  3. Registration Eudravigilance

    Publication | 30-08-2022

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

    Publication | 25-08-2022

  5. Flowchart Adverse events in IVD performance studies

    Publication | 12-08-2022

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

    Form | 15-07-2022

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

    Form | 15-07-2022

  8. 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

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

    Letter | 14-07-2022

  10. A1. Template cover letter for the competent authority

    Letter | 14-07-2022