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Instruction sheet for Site Suitability Declaration (VGO)
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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 ...
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General terms and conditions fees CCMO
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EU template Declaration of interest investigator
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EU template Declaration of interest investigator
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Registration Eudravigilance
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Overview of documents to be submitted for IVD performance studies
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Flowchart Adverse events in IVD performance studies
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A1. Template cover letter amendment for the competent authority
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Standard research file M1. Template progress report