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  1. 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

  2. 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

  3. Template CV investigator

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

    Publication | 31-08-2021

  4. Content simplified IMPD

    Publication | 31-08-2021

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

    Publication | 18-05-2021

  6. Review of a clinical investigation with a medical device - guidance document for MRECs

    Publication | 17-05-2021

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

    Publication | 17-05-2021

  8. Appendix F. MDR and WMO relevant texts for assessment

    Publicatie | 03-05-2021

  9. B1a. Eudamed form

    Below you can download the Eudamed form. Please use Appendix A to declare an additional medical device. Please use Appendix B to ...

    Form | 21-04-2021

  10. D2. IMDD-MDR template

    Form | 14-12-2020

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