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  1. Template cover letter

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

    Publication | 11-11-2021

  2. Template CV investigator

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

    Publication | 31-08-2021

  3. Content simplified IMPD

    Publication | 31-08-2021

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

    Publication | 18-05-2021

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

    Publication | 17-05-2021

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

    Publication | 17-05-2021

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

    Publicatie | 03-05-2021

  8. Flow chart Adverse events in research with medical devices

    Publication | 24-04-2021

  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. Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus

    Publication | 23-02-2021

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