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Demystifying EU CTR, MDR and IVDR | ICON plc
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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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</div> </div> <div class="off-canvas-element__content-revealer"></div> </div> <div class="off-canvas-element__overlay fade"></div> <div id="579a3486-e762-4c27-ae44-1e58c3de8ee4"> <div> <div class="file file--with-thumbnail"> <div class="container-fluid container-fluid--xl"> <a href="https://icon.widen.net/s/kbt989n825" target="_blank" title="Infographic: A simplified view of the submission requirements for EU MDR and the risk classifications of medical devices."> <span class="file__thumbnail"> <div> <div><div><img src="https://icon.widen.net/content/03375347-783c-4b24-a4b5-3e1faf553b8b/web/infographic-thumbail-demystifying-eu.jpg?h=240&itok=smBonob6" width="170" height="240" alt="infographic demystifying EU" loading="lazy" title="infographic demystifying EU" /> </div> </div> </div> </span> <span class="file__details"> <h3>Infographic: A simplified view of the submission requirements for EU MDR and the risk classifications of medical devices.</h3> </span> </a> </div> </div> </div> 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