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  1. Template compliance with use of biological samples

    The template below is available in Rich Text Format and as PDF document.

    Publication | 27-01-2022

  2. Template compliance with national requirements on data protection

    The template below is available in Rich Text Format and as PDF document.

    Publication | 27-01-2022

  3. Template compensation trial participants, investigator, funding and other arrangements NL

    The template below is available in Rich Text Format and as PDF document.

    Publication | 11-11-2021

  4. Template recruitment procedure NL

    The template below is available in Rich Text Format and as PDF document.

    Publication | 11-11-2021

  5. Template cover letter

    The template below is available in OpenDocument Text and as PDF document.

    Publication | 11-11-2021

  6. Template CV investigator

    The template below is available in Rich Text Format and as PDF document.

    Publication | 31-08-2021

  7. Content simplified IMPD

    Publication | 31-08-2021

  8. Overview of documents to be submitted for clinical investigations with medical devices

    Publication | 18-05-2021

  9. Review of a clinical investigation with a medical device – guidance document for MRECs

    Publication | 17-05-2021

  10. Explanatory note to flowchart to determine which MDR article is applicable to the clinical investigation

    Publication | 17-05-2021