B1a. Eudamed form | The Central Committee on Research Involving Human Subjects

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

Download: Standard research file medical devices B1a. Eudamed form (MDR)
Form21-04-2021PDF document2.61 MB21 pages
Download: Standard research file medical devices B1a. Eudamed form Appendix A (MDR)
Form21-04-2021PDF document1.98 MB4 pages
Download: Standard research file medical devices B1a. Eudamed form Appendix B (MDR)
Form21-04-2021PDF document1.46 MB2 pages

Download: Standard research file medical devices B1a. Eudamed form (MDR)

Download: Standard research file medical devices B1a. Eudamed form Appendix A (MDR)

Download: Standard research file medical devices B1a. Eudamed form Appendix B (MDR)