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

    Publication | 25-08-2022

  2. Flowchart Adverse events in IVD performance studies

    Publication | 12-08-2022

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

    Form | 15-07-2022

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

    Form | 15-07-2022

  5. 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

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

    Letter | 14-07-2022

  7. Standard research file M1. Template progress report

    Publication | 29-06-2022

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

    Publication | 31-05-2022

  9. Template protocol

    Publication | 25-05-2022

  10. Template IMPD Efficacy and Safety

    Publication | 02-05-2022