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Overview of documents to be submitted for clinical investigations with medical devices
Review of a clinical investigation with a medical device – guidance document for MRECs
Explanatory note to flowchart to determine which MDR article is applicable to the clinical investigation
Appendix F. MDR and WMO relevant texts for assessment
Flow chart Adverse events in research with medical devices
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 ...