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B1a. Eudamed-formulier

Here you can download the latest version of the Eudamed form. Please use Appendix A to declare an additional IVD and Appendix B to declare an additional comparator. Appendix C is applicable when a new participating centre is added to the performance study.

Download in English: 'Standard research file IVD performance studies B1a. Eudamed-formulier'

PDF document | 20 pages | 1.4 MB

Form | 10-01-2023

Download in English: 'Standard research file IVD performance studies B1a. Eudamed-formulier Appendix A'

PDF document | 5 pages | 1,005 kB

Form | 10-01-2023

Download in English: 'Standard research file IVD performance studies B1a. Eudamed-formulier Appendix B'

PDF document | 2 pages | 949 kB

Form | 10-01-2023

Download in English: 'Standard research file IVD performance studies B1a. Eudamed-formulier Appendix C'

PDF document | 1 page | 858 kB

Form | 10-01-2023