Demystifying EU CTR, MDR and IVDR

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But for every new development there are many regulatory hurdles to overcome. </p><p>In the EU, sponsors must comply with three major regulatory requirements: Clinical Trials Regulation (CTR), Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation (IVDR). Additionally, sponsors may face separate national regulation, ethical and safety requirements. </p></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="5e17ddf1-74e5-4b73-a0dd-57fa2058eb79"> <div class="container-fluid container-fluid--xl text-and-picture-wrapper "> <div class="row"> <div class="col-sm"> <div class="text-picture-wrapper"> <div class="text-picture text-picture--text-only text-left with-separator--top"> <div> <div class="text-picture__text"> <h3> Download the whitepaper to learn more about: </h3> <div><ul><li>CTIS and EUDAMED electronic portals</li><li>Conformity assessment of medical devices and in-vitro diagnostic devices</li><li>Clinical performance and clinical evaluation under MDR and IVDR</li><li>EU MDR and IVDR submission requirements and timelines</li><li>Submission strategies for combination studies</li></ul></div> </div> </div> </div> </div> </div> </div> </div> </div> <div id="be311135-6c4d-4697-b2b4-54f99371b9c4" 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