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Content simplified IMPD
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Overview of documents to be submitted for clinical investigations with medical devices
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Review of a clinical investigation with a medical device – guidance document for MRECs
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Explanatory note to flowchart to determine which MDR article is applicable to the clinical investigation
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Appendix F. MDR and WMO relevant texts for assessment
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Flow chart Adverse events in research with medical devices
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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 ...
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Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
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D2. IMDD-MDR template
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Template Clinical Trial Agreement for investigator-initiated research for use with VGO