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