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Medical Technology Regulations - MedTech Europe
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d="M17.9,7.17c.16.08.17.1.17.3q0,13.82,0,27.63a4.43,4.43,0,0,0,.05.72,1.49,1.49,0,0,0,1.29,1.23h.18a1.43,1.43,0,0,0,1-.37,1.73,1.73,0,0,0,.54-1.33V7.28l.26-.13A3.79,3.79,0,0,0,23.27,3a3.8,3.8,0,0,0-7.39-.24A3.72,3.72,0,0,0,17.9,7.17Zm.87-3.37A.85.85,0,0,1,19.53,3h0a.74.74,0,0,1,.51.24.88.88,0,0,1,.27.64.75.75,0,0,1-.72.69h0A.88.88,0,0,1,19,4.3.67.67,0,0,1,18.77,3.8Z"/> <path d="M23.05,18.66c0,.84,0,1.69,0,2.54v6.62c0,.81,0,1.63,0,2.44a1.47,1.47,0,0,0,.51,1.13,1.53,1.53,0,0,0,1,.39h.17a1.56,1.56,0,0,0,1.36-1.67V12.74a1,1,0,0,1,1.11-1.12h.61c.52,0,1,0,1.64,0,0,0,0,0,.05.08a3.76,3.76,0,0,0,4.49,2,3.83,3.83,0,0,0-.56-7.47,3.84,3.84,0,0,0-4,2.23c-.61,0-1.33,0-2,0a4.1,4.1,0,0,0-3.1,1.18A4.26,4.26,0,0,0,23,12.79C23.08,14.74,23.06,16.73,23.05,18.66ZM33,9.25h0a.78.78,0,0,1,.76.79.71.71,0,0,1-.21.51.76.76,0,0,1-.54.23.77.77,0,0,1-.54-.2.82.82,0,0,1-.2-.57A.72.72,0,0,1,33,9.25Z"/> <path d="M5.59,13.79a3.87,3.87,0,0,0,4.05-2.25h2c.88,0,1.26.37,1.26,1.26V30.17a1.5,1.5,0,0,0,1.38,1.5h.18a1.55,1.55,0,0,0,1.43-1.06,2.35,2.35,0,0,0,.07-.69V18.61q0-3.13,0-6.27A4,4,0,0,0,12.55,8.5a18.56,18.56,0,0,0-2.23-.09H9.7c-.14,0-.14,0-.2-.11A3.7,3.7,0,0,0,6.34,6.19,3.8,3.8,0,0,0,3.28,7.41a3.72,3.72,0,0,0-1,3.09A3.84,3.84,0,0,0,5.59,13.79ZM5.34,10a.7.7,0,0,1,.22-.52.59.59,0,0,1,.53-.23.74.74,0,0,1,.74.72.79.79,0,0,1-.21.55.77.77,0,0,1-.52.22.85.85,0,0,1-.54-.21A.75.75,0,0,1,5.34,10Z"/> </svg> Market Data </a> </li> <li> <a href="https://www.medtecheurope.org/research-and-innovation/" class="yellow"> <svg class="icon topic-icon icon-research-and-innovation" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 44.04 50.65"><path d="M44,24.6a3.86,3.86,0,0,0-3.74-4.14,4.78,4.78,0,0,0-2.29.38,4.33,4.33,0,0,0-4-2.43h-.1c-1.45,0-2.91,0-4.36,0H27.9V16.21h4.66c.73,0,1.6-.3,1.61-1.7V1.71C34.16.3,33.29,0,32.56,0H11.1A1.47,1.47,0,0,0,9.52,1.71V14.47c0,.75.17,1.74,1.63,1.74h4.62v2.21H10a4.26,4.26,0,0,0-3.46,1.7,6.88,6.88,0,0,0-.48.76,4.69,4.69,0,0,0-3.16-.33A4,4,0,0,0,0,24.67q0,3.09,0,6.18v3.63c0,.77,0,1.54,0,2.31a3.84,3.84,0,0,0,3.24,4,5.14,5.14,0,0,0,2.41-.16,4.48,4.48,0,0,0,4.28,3.29h.38A6.32,6.32,0,0,0,7,49.4v1.25H21V49.4A6.18,6.18,0,0,0,17.71,44h8.73a6.31,6.31,0,0,0-3.31,5.43v1.25H37.21V49.4a6.21,6.21,0,0,0-2.68-5,6.52,6.52,0,0,0-.72-.43l.76,0a4.31,4.31,0,0,0,3.63-2.81,3.8,3.8,0,0,0,.18-.47,4,4,0,0,0,.52.15,6.17,6.17,0,0,0,1.4.09c2.18,0,3.71-1.74,3.73-4.15C44.05,32.64,44.05,28.56,44,24.6ZM5.36,32.24q0,2.2,0,4.41c0,1.15-.52,1.25-1,1.26-.2,0-.4,0-.6,0s-1,0-1-1.25c0-.8,0-1.6,0-2.4V24.87c0-1.24.4-1.47,1.3-1.47H4.2a1.17,1.17,0,0,1,.74.15,1.15,1.15,0,0,1,.43,1c0,1.47,0,2.94,0,4.41Zm7-19V3H31.38V13.25Zm12.79,3v2.13H18.57V16.24ZM18.3,48.15H9.7A4.52,4.52,0,0,1,14,45.49a5,5,0,0,1,2.9.9A4,4,0,0,1,18.3,48.15Zm16.17,0h-8.6a4.52,4.52,0,0,1,4.3-2.66,5,5,0,0,1,2.9.9A3.88,3.88,0,0,1,34.47,48.15Zm.77-7.66a1.68,1.68,0,0,1-1.19.51h0c-1.75,0-3.5,0-5.26,0h-10c-2.91,0-5.82,0-8.74,0h0a1.83,1.83,0,0,1-1.77-1.53,4,4,0,0,1-.06-.78V33.91c0-3.43,0-6.87,0-10.3a2.47,2.47,0,0,1,.67-1.77A1.69,1.69,0,0,1,10,21.33c2.3,0,4.61,0,6.92,0H34a1.76,1.76,0,0,1,1.82,1.52,2.65,2.65,0,0,1,.07.7v5.29c0,3.31,0,6.62,0,9.93A2.35,2.35,0,0,1,35.24,40.49Zm5.54-2.69a1.9,1.9,0,0,1-1.91-.25,1.25,1.25,0,0,1-.21-.83V35.66q0-5.52,0-11c0-1.08.59-1.21,1-1.21h.5c.56,0,1.08.16,1.08,1.32,0,1.4,0,2.8,0,4.2v3.47c0,1.39,0,2.78,0,4.17C41.27,37.37,41,37.63,40.78,37.8Z"/><path d="M20.88,23.54H11.47c-.74,0-1.61.31-1.61,1.75V37c0,1.47.89,1.78,1.63,1.78h9.37c.75,0,1.64-.3,1.65-1.76V25.31C22.5,24.14,22,23.54,20.88,23.54Zm-1.16,12.3H12.66V26.52h7.06Z"/><path d="M31.77,35.87q-3.48,0-7,0a1.57,1.57,0,0,0-1.24.73,1.42,1.42,0,0,0-.05,1.45,1.54,1.54,0,0,0,1.37.75h6.87a1.44,1.44,0,0,0,1.52-1.47,1.44,1.44,0,0,0-1.49-1.47Z"/><path d="M30.22,29.7H28.44c-1.18,0-2.37,0-3.55,0a1.45,1.45,0,1,0-.14,2.9c.59,0,1.17,0,1.75,0h5.21a1.57,1.57,0,0,0,1.16-.45,1.48,1.48,0,0,0-1.15-2.48Z"/><path d="M24.86,26.49h6.9a1.45,1.45,0,0,0,1.5-1.43,1.42,1.42,0,0,0-1.47-1.51c-2.33,0-4.65,0-7,0a1.57,1.57,0,0,0-1.24.69,1.44,1.44,0,0,0-.07,1.47A1.54,1.54,0,0,0,24.86,26.49Z"/><path d="M18.36,5.35a2.77,2.77,0,1,0,2.77,2.77A2.78,2.78,0,0,0,18.36,5.35Zm0,3.54a.77.77,0,0,1,0-1.54.77.77,0,0,1,0,1.54Z"/><path d="M25.68,5.34a2.77,2.77,0,1,0,2.77,2.77A2.78,2.78,0,0,0,25.68,5.34Zm0,3.54a.77.77,0,1,1,.77-.77A.78.78,0,0,1,25.68,8.88Z"/></svg> Research and Innovation </a> </li> <li> <a href="https://www.medtecheurope.org/innovative-health-initiative-ihi-the-flagship-partnership-for-healthcare-research-innovation-in-europe/" class="yellow"> <svg class="icon topic-icon icon-partnership" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink" viewBox="0 0 24.76 24"><path d="m23.88,6.45h-2c-.5,0-.97.2-1.33.55-.06.06-.11.13-.16.19l-4.87-1.91c-.4-.15-.83-.2-1.24-.13-.42.07-.81.24-1.14.51l-1.13.93-.91-.91c-.26-.27-.6-.44-.96-.52-.37-.07-.74-.04-1.09.11l-2.92,1.21-1.46.29c-.09-.29-.24-.55-.46-.77-.35-.36-.83-.55-1.33-.55H.88c-.49,0-.88.39-.88.88v9c0,.49.39.88.88.88h2c.5,0,.97-.2,1.33-.55.22-.22.37-.49.46-.78l1.38.27,3.39,3.39c.21.21.47.37.76.47.18.06.38.09.57.09.11,0,.21,0,.32-.03l.5-.09c.39-.07.74-.25,1.01-.52.28-.28.46-.63.52-1.01l.07-.4,1.1-.19c.12-.02.23-.07.33-.14.96,0,1.65,0,2.13,0,1.17,0,1.21,0,1.29-.02l2.18-.4s.03-.01.05-.02c.08.14.17.27.28.38.35.36.83.55,1.33.55h2c.49,0,.88-.39.88-.88V7.33c0-.49-.39-.88-.88-.88ZM3,14.33l-.12.12h-1.12v-7.24h1.12l.12.12v7Zm9.28,1.08c-.37.06-.65.35-.72.72l-.17,1.01-.04.07-.06.03-.5.09h-.04s-.07-.03-.07-.03l-3.58-3.58c-.12-.12-.28-.21-.46-.24l-1.89-.36v-4.55l1.79-.36c.06-.01.11-.03.16-.05l3-1.24.07-.03.06.06.79.79-1.17.96c-.3.24-.5.59-.57.96-.07.38-.01.77.17,1.11.19.34.48.6.84.74.36.14.76.15,1.12.03l2.56-.84,1.89,1.89-.11.65-1.1.19c-.37.06-.65.35-.72.72l-.19,1.1-1.1.19Zm5.51-.46c-.27,0-1.26,0-2.11,0l.61-.11c.37-.06.65-.35.72-.72l.29-1.71c.05-.28-.04-.57-.25-.77l-1.64-1.64c.28-.22.41-.6.29-.96-.15-.46-.65-.71-1.11-.56l-3.56,1.17,3.21-2.64c.08-.07.19-.12.3-.13.11-.02.22,0,.32.03l5.04,1.98.07.04v.08s0,5.43,0,5.43l-.1.12-2.11.39Zm5.21.5h-1.12l-.12-.12.04-7.09s.05-.04.08-.04h1.12v7.24Z"/></svg> Innovative Health Initiative (IHI) </a> </li> </ul> </div> </div> <div class="header-submenu__column"> <p> <strong>Sector Groups</strong><br /> MedTech Europe sector groups bring together company experts to drive forward key healthcare domains, helping to address issues facing these sectors and shaping their future. We have dedicated groups focused on cardiovascular health, ophthalmology, diabetes, orthopaedics, and AMR/HAI. </p> <div> <ul> <li> <a href="https://www.medtecheurope.org/cancer-wwwo/" class="pink"> <svg class="icon topic-icon icon-cardiovascular" viewBox="0 0 26.03 40.73" xmlns="http://www.w3.org/2000/svg"><g fill="none" stroke="#51398a" stroke-miterlimit="10" stroke-width="1.5"><path d="m13.1 26.41-9.3 12.89-2.92-5.43c2.06-2.91 4.12-5.81 6.17-8.72.86-1.21 1.72-2.42 2.58-3.64-.56-.8-1.13-1.59-1.69-2.39-1.87-2.64-3.87-5.2-3.87-8.59 0-.56.04-1.13.13-1.68.08-.48.18-.96.32-1.42.32-1.08.81-2.11 1.47-3.03.27-.38.57-.73.9-1.07 1.24-1.3 2.61-2.06 4.4-2.4 2.36-.45 5.05-.1 6.92 1.47 1.94 1.63 3.23 3.95 3.63 6.45.09.56.13 1.12.13 1.68 0 3.38-2 5.94-3.87 8.59-.57.8-1.13 1.6-1.7 2.4.86 1.21 1.72 2.43 2.58 3.64 2.06 2.91 4.12 5.81 6.17 8.72l-2.92 5.43-9.13-12.9-3.47-4.9"/><path d="m16.4 21.51-3.39-4.77"/><path d="m17.96 9.31c0-2.76-2.24-4.5-5-4.5s-5 1.74-5 4.5c1.09 1.53 3.97 5.9 5.06 7.43 1.09-1.53 3.86-5.89 4.94-7.43z"/></g></svg> Cancer </a> </li> <li> <a href="https://www.medtecheurope.org/diabetes/" class="pink"> <svg class="icon topic-icon icon-diabetes" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 31.79 50.93"> <path d="M31.76,3.13a3,3,0,0,0-.07-.32A3.45,3.45,0,0,0,28.21,0H3.59A3.47,3.47,0,0,0,0,3.57C0,5.27,0,7,0,8.68v9.84c0,9.52,0,10.84,0,18a3.59,3.59,0,0,0,2.54,3.59,3.3,3.3,0,0,0,.86.12H14.19V50.93h3.43V40.19H28.37a3.5,3.5,0,0,0,3.36-3l0-.14,0-33.66Zm-28,.29H28.08c.18,0,.25,0,.26,0a1.89,1.89,0,0,1,0,.28V26.85l-24.94,0V3.75c0-.22,0-.3,0-.3A1.15,1.15,0,0,1,3.76,3.42ZM3.67,36.76H3.44a.84.84,0,0,1,0-.24V30.26H14.2v6.5Zm24.69,0H17.61v-6.5H28.36v6.25A1.5,1.5,0,0,0,28.36,36.75Z"/> <path d="M17.16,24.57a5.34,5.34,0,0,0,3.9-7C19.88,14,17.92,10.77,15.91,7.26c-2.15,3.73-4.29,7.15-5.35,11.09a4.37,4.37,0,0,0-.06,1.8A5.43,5.43,0,0,0,17.16,24.57Z"/> </svg> Diabetes </a> </li> <li> <a href="https://www.medtecheurope.org/ophtalmology/" class="pink"> <svg class="icon topic-icon icon-ophtalmology" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 51.35 51.28"> <path d="M51.34,23.66c-.08-.44-.16-.88-.23-1.33a24.06,24.06,0,0,0-.59-2.95C47.47,8.77,40.36,2.34,29.41.27c-.34-.07-.68-.12-1-.18L27.9,0H23.79l-.17,0c-.74.18-1.5.33-2.25.48a27.2,27.2,0,0,0-5,1.32C7.07,5.62,1.63,12.65.19,22.72a1.89,1.89,0,0,1-.1.41L0,23.39l0,4.39.09.6c.06.34.12.67.17,1A25.56,25.56,0,0,0,25.42,51.28,24.9,24.9,0,0,0,28,51.15c10.73-1.09,18.12-6.93,22-17.35a26.2,26.2,0,0,0,1-4c.11-.61.23-1.22.36-1.82l0-4.15ZM25.66,48.35h0a22.24,22.24,0,0,1-16-6.62A22.66,22.66,0,0,1,25.63,3h.17a22.69,22.69,0,0,1-.14,45.38Z"/> <path d="M25.67,9.36h0A16.26,16.26,0,0,0,14.11,14.2,16,16,0,0,0,9.36,25.53a16.49,16.49,0,0,0,4.88,11.76A16,16,0,0,0,25.62,42h.1a16.32,16.32,0,0,0,0-32.63ZM25.6,39h0a13.35,13.35,0,0,1,.12-26.69h0a13.2,13.2,0,0,1,9.38,3.91A13.48,13.48,0,0,1,39,25.85,13.33,13.33,0,0,1,25.6,39Z"/> <path d="M27.5,16.67c-.69.6-1,.7-1.39.54l-.17-.07-.18,0-.62.07a10.59,10.59,0,0,0-1.44.2,8.48,8.48,0,0,0,2,16.74A8.93,8.93,0,0,0,27.46,34,8.5,8.5,0,0,0,34,23.92a1.39,1.39,0,0,1,.23-1.25,4.46,4.46,0,0,0-.77-5.86A4.52,4.52,0,0,0,27.5,16.67Zm1.23,3.59a1.7,1.7,0,0,1,.49-1.2,1.55,1.55,0,0,1,1.12-.5h0a1.54,1.54,0,0,1,1.09.46,1.68,1.68,0,0,1,.51,1.2,1.66,1.66,0,0,1-.51,1.19,1.45,1.45,0,0,1-1.12.47A1.68,1.68,0,0,1,28.73,20.26Zm.12,10a5.53,5.53,0,1,1-3.36-10h.23a5.07,5.07,0,0,0,1.58,3.49,5.08,5.08,0,0,0,3.78,1.12A5.28,5.28,0,0,1,28.85,30.21Z"/> <path d="M16.12,25.62c.7-5.74,3.82-8.85,9.54-9.48l.65-.07V13.42l-.7,0a11.61,11.61,0,0,0-9.11,3.95c-2.25,2.48-3.42,5.65-3.06,8.29l.08.63H16Z"/> <polygon points="13.56 28.59 14.69 31.66 17.39 30.36 16.3 27.71 13.56 28.59"/> </svg> Ophthalmology </a> </li> <li> <a href="https://www.medtecheurope.org/amr-and-hais/" class="pink"> <svg class="icon topic-icon icon-amr" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 51.85 51.04"> <path d="M51,24a4.8,4.8,0,0,0-1.31-.59,6.65,6.65,0,0,0-4.84.4,3.1,3.1,0,0,1-2.09.34,17.53,17.53,0,0,0-1.18-5,7,7,0,0,0,3.06-2.7,2.49,2.49,0,0,1,1.56-1,4.16,4.16,0,0,1,.48-.09l.29,0a1.75,1.75,0,1,0-.35-3.49,3.72,3.72,0,0,0-.81.09,6.75,6.75,0,0,0-4.29,2.8A3.31,3.31,0,0,1,40,16.07a17.19,17.19,0,0,0-3.54-3.71,6.73,6.73,0,0,0,1.27-3.64,3,3,0,0,1,1-2A3,3,0,0,1,39,6.56a4.47,4.47,0,0,0,.4-.34,1.69,1.69,0,0,0,.21-2.28,1.74,1.74,0,0,0-2.26-.57,4.54,4.54,0,0,0-1.1.75,6.23,6.23,0,0,0-2.12,4.52,2.84,2.84,0,0,1-.68,1.83A18.26,18.26,0,0,0,28.36,9a6.89,6.89,0,0,0-.74-3.79,3.06,3.06,0,0,1-.12-2.35l.06-.17a3.37,3.37,0,0,0,.18-.7A1.81,1.81,0,0,0,26.56.11a1.84,1.84,0,0,0-2.11.65,4.15,4.15,0,0,0-.51,1,6.26,6.26,0,0,0,.32,5.15,3,3,0,0,1,.33,2,19.15,19.15,0,0,0-5.07,1.17,7.09,7.09,0,0,0-2.81-3,2.43,2.43,0,0,1-1-1.48,2.69,2.69,0,0,1-.08-.47c0-.17,0-.33-.09-.49A1.69,1.69,0,0,0,14,3.21a1.77,1.77,0,0,0-1.82,1.16,2.93,2.93,0,0,0-.07,1.32,6.62,6.62,0,0,0,2.94,4.6,3.13,3.13,0,0,1,1.25,1.51,17.69,17.69,0,0,0-3.77,3.48A7.07,7.07,0,0,0,8.86,14a3,3,0,0,1-2.09-1.11l-.14-.17a2.83,2.83,0,0,0-.32-.37A1.8,1.8,0,0,0,4,12.19a1.72,1.72,0,0,0-.56,2.24,4.84,4.84,0,0,0,.83,1.14,6.67,6.67,0,0,0,4.61,2,2.83,2.83,0,0,1,1.76.66,18.51,18.51,0,0,0-1.52,5,7.56,7.56,0,0,0-4.1.84,1.91,1.91,0,0,1-.31.08l-.14,0a3.61,3.61,0,0,1-2.15-.27,1.72,1.72,0,0,0-2.21.81,1.76,1.76,0,0,0,.52,2.23,2.72,2.72,0,0,0,.67.38,6.15,6.15,0,0,0,5.54-.14,3.05,3.05,0,0,1,2-.32,17.66,17.66,0,0,0,1.19,5l-.11.05a6.23,6.23,0,0,0-2.7,2.31,3.1,3.1,0,0,1-2.46,1.47,2,2,0,0,0-.56.12,1.73,1.73,0,0,0-1.15,1.86,1.69,1.69,0,0,0,1.65,1.51A5.12,5.12,0,0,0,6.06,39a6.66,6.66,0,0,0,4.17-2.8A3.29,3.29,0,0,1,11.75,35l.32.4c.46.57.9,1.11,1.39,1.62s1.13,1.07,1.61,1.49l.25.21a6.86,6.86,0,0,0-1.26,3.57,3,3,0,0,1-1.17,2.14l-.16.12a3.28,3.28,0,0,0-.39.34,1.69,1.69,0,0,0-.19,2.19,1.83,1.83,0,0,0,2.12.68,3.87,3.87,0,0,0,1.09-.66,6.27,6.27,0,0,0,2.29-4.66,3,3,0,0,1,.69-1.84,17.88,17.88,0,0,0,5.05,1.5,5.5,5.5,0,0,0,.4,2.91A4.17,4.17,0,0,1,24,48.82a1.47,1.47,0,0,0,.07,1.41,1.8,1.8,0,0,0,1.47.81h.15A2,2,0,0,0,27.8,49.6a6.24,6.24,0,0,0-.18-5.45,3.21,3.21,0,0,1-.34-2l.49-.07c.74-.12,1.44-.22,2.15-.39s1.43-.4,2.11-.63l.31-.1a7.05,7.05,0,0,0,2.71,3,2.64,2.64,0,0,1,1.14,1.91c0,.07,0,.13,0,.2a3,3,0,0,0,.07.51,1.76,1.76,0,0,0,1.82,1.28,1.73,1.73,0,0,0,1.65-1.55,4.86,4.86,0,0,0-.13-1.5,6.58,6.58,0,0,0-2.81-4,3.26,3.26,0,0,1-1.27-1.52,17.4,17.4,0,0,0,3.77-3.48,7.66,7.66,0,0,0,3.94,1.29,2.88,2.88,0,0,1,1.79,1c.06.06.11.13.17.2a2.69,2.69,0,0,0,.36.39,1.82,1.82,0,0,0,2.31.19,1.68,1.68,0,0,0,.47-2.37,6.41,6.41,0,0,0-5.38-3,2.86,2.86,0,0,1-1.73-.66,17.69,17.69,0,0,0,1.51-5A6.79,6.79,0,0,0,46.53,27a3.48,3.48,0,0,1,1.17-.27,3.57,3.57,0,0,1,1.73.36,1.77,1.77,0,0,0,2.22-.78A1.71,1.71,0,0,0,51,24ZM39.38,25.41a13,13,0,0,1-3.93,9.33,13.6,13.6,0,0,1-9.59,3.88,13.36,13.36,0,0,1-9.42-3.87,13,13,0,0,1-3.92-9.38,13.43,13.43,0,0,1,26.86,0Z"/> <path d="M21.43,27.15h0a4.11,4.11,0,0,0-4.11,4,4.09,4.09,0,0,0,7,2.87,4,4,0,0,0,1.25-2.86A4.16,4.16,0,0,0,21.43,27.15Zm.48,4.17a.45.45,0,0,1-.14.33h0a.52.52,0,0,1-.38.14.51.51,0,0,1-.48-.47.54.54,0,0,1,.17-.34.48.48,0,0,1,.32-.17.49.49,0,0,1,.33.16A.5.5,0,0,1,21.91,31.32Z"/> <path d="M33.56,17.37a4.12,4.12,0,0,0-4.16,3.92,4.06,4.06,0,0,0,1.18,2.88,4.16,4.16,0,0,0,2.88,1.24,4.11,4.11,0,0,0,4.14-4,4,4,0,0,0-1.16-2.83,4.13,4.13,0,0,0-2.83-1.23ZM33,21.5a.55.55,0,0,1,.18-.35.39.39,0,0,1,.64,0,.56.56,0,0,1,.18.36.43.43,0,0,1-.15.33.5.5,0,0,1-.37.14h0A.55.55,0,0,1,33,21.5Z"/> <path d="M29.24,23.85a4.65,4.65,0,0,0-1.5-.73,3.9,3.9,0,0,0-3.48.65,1.64,1.64,0,0,0-.59,2,1.6,1.6,0,0,0,1.89,1.13l.11,0c.88-.26,1.44-.39,1.86-.07l.19.15h.34a1.72,1.72,0,0,0,1.18-3.08Z"/> <path d="M33.38,30.27v.39h0l0-.39h0l-.22.06a4,4,0,0,0-3.15,3A1.77,1.77,0,0,0,31,35.56a1.87,1.87,0,0,0,.62.1,1.75,1.75,0,0,0,1.67-1.21,1,1,0,0,1,.78-.72,1.66,1.66,0,0,0,1.28-2A2.09,2.09,0,0,0,33.38,30.27Z"/> <path d="M24.79,17.54a1.22,1.22,0,0,1,1.16,0,2.1,2.1,0,0,0,.92.22,1.54,1.54,0,0,0,.56-.1,1.58,1.58,0,0,0,.93-.88,1.77,1.77,0,0,0-.86-2.37,8.6,8.6,0,0,0-1.33-.47l-.5-.15-.23-.08-.24.08-.57.18a9.14,9.14,0,0,0-1.45.53,1.55,1.55,0,0,0-.81.93,1.84,1.84,0,0,0,.17,1.44A1.64,1.64,0,0,0,24.79,17.54Z"/> <path d="M18.76,25.51A1.73,1.73,0,0,0,19.53,24a2,2,0,0,0-1-1.58,4.59,4.59,0,0,0-4.5,0,1.75,1.75,0,0,0-.65,2.18,1.79,1.79,0,0,0,1,1,1.64,1.64,0,0,0,1.23,0,1.77,1.77,0,0,1,1.63,0,1.56,1.56,0,0,0,.7.16A1.53,1.53,0,0,0,18.76,25.51Z"/> </svg> Antimicrobial Resistance (AMR) and Healthcare Associated Infections (HAIS) </a> </li> <li> <a href="https://www.medtecheurope.org/cardiovascular/" class="pink"> <svg class="icon topic-icon icon-cardiovascular" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 54.28 50.92"> <path 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</svg> Cardiovascular </a> </li> <li> <a href="https://www.medtecheurope.org/homecare-community-care/" class="pink"> <svg class="icon topic-icon icon-homecare" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 53.61 51.04"> <path 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</svg> Homecare & Community Care </a> </li> <li> <a href="https://www.medtecheurope.org/orthopaedic/" class="pink"> <svg class="icon topic-icon icon-orthopedics" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 41.25 50.88"> <path 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d="M22.25,46.18A1.61,1.61,0,0,0,20.47,45h0c-.49.08-1.46.53-1.54,1.13a13.58,13.58,0,0,0,0,3.54,1.56,1.56,0,0,0,1.68,1.25l.29,0a1.62,1.62,0,0,0,1.48-1.51c.05-.33.07-.66.09-1.05l0-.63a3.31,3.31,0,0,1,0-.34A5.58,5.58,0,0,0,22.25,46.18Z"/> </svg> Orthopaedic </a> </li> </ul> </div> </div> </div> </div> <div class="header-submenu header-submenu--blogs menu-blogs"> <div class="header-submenu__content"> <div class="header-submenu__column"> <div> <a href="https://www.thisismedtech.com" target="_blank" onclick="AK_Analytics.sendEvent('navigation-click', 'https://www.thisismedtech.com')"><img src="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/logo-this-is-medtech.jpg" alt=""></a> </div> <p>Real stories of people’s lives transformed by medtech.</p> <div> <a href="https://www.thisismedtech.com" target="_blank" class="btn" onclick="AK_Analytics.sendEvent('navigation-click', 'https://www.thisismedtech.com')"><span class="span-split">Go to the blog</span></a> </div> </div> <div class="header-submenu__column"> <div> <a href="http://www.medtechviews.eu" target="_blank" onclick="AK_Analytics.sendEvent('navigation-click', 'http://www.medtechviews.eu')"><img src="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/logo-medtech-views.jpg" alt=""></a> </div> <p>Your platform for dialogue about medical technologies.</p> <div> <a href="http://www.medtechviews.eu" target="_blank" class="btn" onclick="AK_Analytics.sendEvent('navigation-click', 'http://www.medtechviews.eu')"><span class="span-split">Go to the blog</span></a> </div> </div> </div> </div> </div> </div> <div id="searchform" class="header-searchform"> <form class="header-searchform__form" action="/search-results/" method="get"> <p class="form-group"> <label for="search">Search on this website</label> <input type="text" name="search" id="search" /> </p> <button onclick="AK_Analytics.sendEvent('search-content', jQuery(event.target).closest('form').find('input#search').val())" class="form-submit" type="submit" title="Search"><i class="fas fa-search"></i></button> <a class="form-close" href="#js-searchform" title="Close search"><i class="far fa-times"></i></a> </form> </div> </div> </header> <div id="main" class="main" role="main"> <section class="intro"> <div class="intro__head"> <div class="intro__head-inner"> <div> <span class="tag">Our Priorities</span> </div> <h1 class="intro__title">Medical Technology Regulations</h1> <nav class="breadcrumb" aria-label="breadcrumb"> <p>You are here :</p><ol><li><a href="https://www.medtecheurope.org/">Homepage</a></li> » <li><a href="https://www.medtecheurope.org/what-we-work-on/">What we work on</a></li> » <li class="breadcrumb_last" aria-current="page">Medical Technology Regulations</li></ol> </nav> <div> <a href="#js-next-section" class="btn"><span class="span-split">Explore</span> <i class="far fa-angle-down"></i></a> </div> </div> </div> <div class="intro__text"> <div class="intro__text-inner"> <p>Medical technologies are tightly regulated in the European Union. Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device.</p> <p>New EU Regulations governing medical devices (MD) and in vitro diagnostic (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the new legislation by the end of the transition periods – 2021 for MDs and 2022 for IVDs.</p> </div> </div> <div class="intro__picture"> <div class="parallax-container"> <div class="parallax"> <img alt="The European Neighbourhood" class="lazyload" src="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/blank.jpg" data-src="https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_399273652-1440x958.jpg" data-srcset="https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_399273652-1440x958.jpg 1440w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_399273652-800x532.jpg 800w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_399273652-886x590.jpg 886w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_399273652-768x511.jpg 768w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_399273652-50x33.jpg 50w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_399273652-250x166.jpg 250w" /> </div> </div> </div> </section> <section class="container"> <div class="container__main"> <section class="single single--work"> <div class="single__main"> <article> </article> <div class="share-container"> <div class="share"> <p>Share this page</p> <ul> <li> <a href="#" class="ssk ssk-linkedin" title="Share on Linkedin"> <svg class="icon"> <use xlink:href="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/sprite.svg#icon-linkedin"></use> </svg> </a> </li> <li> <a href="#" class="ssk ssk-twitter" title="Share on Twitter"> <svg class="icon"> <use xlink:href="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/sprite.svg#icon-twitter"></use> </svg> </a> </li> <li> <a href="#" class="ssk ssk-facebook" title="Share on Facebook"> <svg class="icon"> <use xlink:href="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/sprite.svg#icon-facebook"></use> </svg> </a> </li> <li> <a href="#" class="ssk ssk-email" title="Share on Email"> <svg class="icon"> <use xlink:href="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/sprite.svg#icon-email"></use> </svg> </a> </li> <li> <a href="#" onclick="window.print();return false;" title="Print"> <svg class="icon"> <use xlink:href="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/sprite.svg#icon-print"></use> </svg> </a> </li> </ul> </div> </div> </div> </section> <section class="single single--work"> <div class="single__main"> <article> <h3>How are medical technologies regulated today?</h3> <p>EU Directives have applied to medical devices (MD) and<em> in vitro</em> diagnostics (IVDs) since the 1990s. Two new EU Regulations were published in May 2017 governing the safety and performance of devices across their lifetime.</p> <p>During a set of transition periods, manufacturers may choose to continue to comply with the applicable Directive or to opt for early compliance with the relevant Regulation. To complete the transition to the new regulatory system, Notified Bodies must be in place and a new electronic platform (Eudamed) must be operational. This work may not be completed until near the end of the transition period.</p> <p>Regardless of whether a product is CE-marked under the Directives or the new Regulations, customers will continue to use medical technologies with a high level of quality, safety and performance; the hallmark of the EU CE-marking system.</p> </article> </div> </section> <span id="topic-bottom" data-title="Medical Technology Regulations"></span> </div> </section> <section class="topics"> <div class="topics__main"> <div class="topics__content"> <h2 class="topics__title">Key topics</h2> <div class="topics__list"> <div class="topics__list-item"> <a href="https://www.medtecheurope.org/new-medical-technology-regulations/symbols-for-compliance-with-the-ivdr-mdr/" class="card-topic"> <div class="card-topic__picture"> <img alt="Undescribed image" class="lazyload" src="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/blank.jpg" data-src="https://www.medtecheurope.org/wp-content/uploads/2024/04/shutterstock_2218037327-1060x360.jpg" data-srcset="https://www.medtecheurope.org/wp-content/uploads/2024/04/shutterstock_2218037327-1060x360.jpg 1060w, https://www.medtecheurope.org/wp-content/uploads/2024/04/shutterstock_2218037327-1440x490.jpg 1440w, https://www.medtecheurope.org/wp-content/uploads/2024/04/shutterstock_2218037327-800x272.jpg 800w, https://www.medtecheurope.org/wp-content/uploads/2024/04/shutterstock_2218037327-768x261.jpg 768w, https://www.medtecheurope.org/wp-content/uploads/2024/04/shutterstock_2218037327-1536x522.jpg 1536w, https://www.medtecheurope.org/wp-content/uploads/2024/04/shutterstock_2218037327-2048x696.jpg 2048w" /> </div> <div class="card-topic__content"> <h3 class="card-topic__title">Symbols for compliance with the IVDR/MDR</h3> <div class="card-topic__excerpt"> <p>MedTech Europe provides information on the use of certain new symbols to support compliance to the Medical Devices Regulation and In vitro Diagnostic Medical Devices Regulation.</p> </div> <p class="card-topic__button btn"><span class="span-split">More</span> <i class="far fa-angle-right"></i></p> </div> </a> </div> <div class="topics__list-item"> <a href="https://www.medtecheurope.org/new-medical-technology-regulations/training-and-education/" class="card-topic"> <div class="card-topic__picture"> <img alt="Training and Education Picture" class="lazyload" src="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/blank.jpg" data-src="https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_439214011-884x590.jpg" data-srcset="https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_439214011-884x590.jpg 884w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_439214011-800x534.jpg 800w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_439214011-768x513.jpg 768w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_439214011-1440x961.jpg 1440w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_439214011-50x33.jpg 50w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_439214011-250x167.jpg 250w" /> </div> <div class="card-topic__content"> <h3 class="card-topic__title">Training and Education</h3> <div class="card-topic__excerpt"> <p>The system for ensuring that medical devices meet the necessary standards, specifications, quality, safety and performance requirements is complex. Understanding EU legislation, they key regulatory actors and the essential steps in the CE marking system is vital to bringing products to market. </p> </div> <p class="card-topic__button btn"><span class="span-split">More</span> <i class="far fa-angle-right"></i></p> </div> </a> </div> <div class="topics__list-item"> <a href="https://www.medtecheurope.org/new-medical-technology-regulations/transition-periods/" class="card-topic"> <div class="card-topic__picture"> <img alt="Transition Period" class="lazyload" src="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/blank.jpg" data-src="https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_1036460617-885x590.jpg" data-srcset="https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_1036460617-885x590.jpg 885w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_1036460617-800x533.jpg 800w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_1036460617-768x512.jpg 768w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_1036460617-1440x960.jpg 1440w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_1036460617-50x33.jpg 50w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_1036460617-250x167.jpg 250w" /> </div> <div class="card-topic__content"> <h3 class="card-topic__title">Transition Periods</h3> <div class="card-topic__excerpt"> <p>Our members are currently managing four- and five-year transition periods to the new regulations. This presents considerable uncertainties that need to be reduced through, for example, practical explanations of what companies can and cannot do over the coming years. It is also essential that we flag our concerns about the feasibility of the transition periods to the authorities. </p> </div> <p class="card-topic__button btn"><span class="span-split">More</span> <i class="far fa-angle-right"></i></p> </div> </a> </div> <div class="topics__list-item"> <a href="https://www.medtecheurope.org/new-medical-technology-regulations/notified-bodies/" class="card-topic"> <div class="card-topic__picture"> <img alt="Notified Bodies Picture" class="lazyload" src="https://www.medtecheurope.org/wp-content/themes/ak-medtecheurope-2018/assets/img/blank.jpg" data-src="https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_355433666-884x590.jpg" data-srcset="https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_355433666-884x590.jpg 884w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_355433666-800x534.jpg 800w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_355433666-768x513.jpg 768w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_355433666-1440x961.jpg 1440w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_355433666-50x33.jpg 50w, https://www.medtecheurope.org/wp-content/uploads/2018/10/shutterstock_355433666-250x167.jpg 250w" /> </div> <div class="card-topic__content"> <h3 class="card-topic__title">Notified Bodies</h3> <div class="card-topic__excerpt"> <p>Notified Bodies are responsible for assessing and (re-)certifying most MDs and IVDs, allowing products to be placed on the market. Both new regulations introduce new obligations for Notified Bodies and will require the assessment of more products than ever before. For example, 35,000 IVDs will be covered by Notified Bodies for the first time. </p> </div> <p class="card-topic__button btn"><span class="span-split">More</span> <i class="far fa-angle-right"></i></p> </div> </a> </div> </div> </div> </div> </section> <section class="banner-work banner-work--color"> <div class="banner-work__main"> <div class="banner-work__content"> <div class="banner-work__left"> <h3 class="banner-work__title">Resources</h3> </div> <div class="banner-work__right"> <ul> <li> <i class="far fa-angle-right"></i> <a href="https://www.medtecheurope.org/resource-library/making-the-eu-medical-devices-regulation-more-workable-infographic/" class="btn-2" target="">Making the EU Medical Devices Regulation more workable – Infographic</a> </li> <li> <i class="far fa-angle-right"></i> <a href="https://www.medtecheurope.org/resource-library/ivdr-a-risk-of-shortages-of-tests/" class="btn-2" target="">IVDR: A risk of shortages of tests?</a> </li> <li> <i class="far fa-angle-right"></i> <a href="https://www.medtecheurope.org/resource-library/the-need-for-virtual-audits-under-the-medical-device-and-in-vitro-diagnostic-regulations-in-the-context-of-a-pandemic-such-as-covid-19/" class="btn-2" target="">The need for ‘virtual audits’ under the Medical Device and In Vitro Diagnostic Regulations in the context of a pandemic, such as COVID-19</a> </li> <li> <i class="far fa-angle-right"></i> <a href="https://www.medtecheurope.org/resource-library/open-letter-to-the-european-commission-on-the-implementation-and-readiness-status-of-the-new-medical-device-regulation-mdr/" class="btn-2" target="">Open letter to the European Commission on the implementation and readiness status of the new Medical Device Regulation (MDR)</a> </li> <li> <i class="far fa-angle-right"></i> <a href="https://www.medtecheurope.org/resource-library/sampling-of-class-b-and-c-ivds-under-ivd-regulation-2017-746-eu/" class="btn-2" target="">Sampling of class B and C IVDs under IVD Regulation 2017/746/EU</a> </li> <li> <i class="far fa-angle-right"></i> <a href="https://www.medtecheurope.org/resource-library/new-medical-technology-regulatory-systems/" class="btn-2" target="">Notified bodies – Capacity vs Workload</a> </li> <li> <i class="far fa-angle-right"></i> <a href="https://www.medtecheurope.org/resource-library/notified-bodies-key-pillar-of-the-medical-technology-regulatory-system/" class="btn-2" target="">Notified Bodies: Key Pillar of the Medical Technology Regulatory System</a> </li> </ul> <a href="https://www.medtecheurope.org/resource-library/?filters[topic]=new-medical-technology-regulations" target="_self" class="btn"><span class="span-split">More resources</span> <i class="fas fa-plus"></i></a> </div> </div> </div> </section> <section class="posts posts--fullwidth"> <div class="posts__main"> <div class="posts__head"> <p class="posts__title">Related content</p> </div> </div> <div class="posts__list"> <div class="posts__list-item"> <div class="post-item "> <div class="tags"> <span class="tag">News</span> <a href="https://www.medtecheurope.org/new-medical-technology-regulations/" class="tag tag--green">New medtech regulations</a> <span class="tag tag--green">Newsletter</span> </div> <h2><a href="https://www.medtecheurope.org/news-and-events/news/medical-device-regulation-in-vitro-device-regulation-article-10a-implementation-eu-commission-qa-published/">Medical Device Regulation & In Vitro Device Regulation – Article 10a implementation – EU Commission Q&A published</a></h2> <p class="date">Posted on 07.11.2024</p> <div class="post-item__buttons"> <a href="https://www.medtecheurope.org/news-and-events/news/medical-device-regulation-in-vitro-device-regulation-article-10a-implementation-eu-commission-qa-published/" class="btn"><span class="span-split">Read more</span> <i class="far fa-angle-right"></i></a> </div> </div> </div> <div class="posts__list-item"> <div class="post-item "> <div class="tags"> <span class="tag">News</span> <a href="https://www.medtecheurope.org/new-medical-technology-regulations/" class="tag tag--green">New medtech regulations</a> <span class="tag tag--green">Newsletter</span> </div> <h2><a href="https://www.medtecheurope.org/news-and-events/news/new-in-draft-texts-of-innovative-health-initiative-calls-9-and-10-published/">New in! 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