{"id":2283,"date":"2021-07-08T17:33:10","date_gmt":"2021-07-08T17:33:10","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=2283"},"modified":"2021-07-08T17:47:38","modified_gmt":"2021-07-08T17:47:38","slug":"imdrf-essential-principles","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/medical-device-sector-regulatory-convergence\/imdrf\/imdrf-essential-principles\/","title":{"rendered":"IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><div class=\"wpcp-wp-lightbox-host wpcp-advanced-image-lightbox-icon-hover\"><a class=\"wpcp-wp-lightbox-image-link\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/07\/IMDRF-Essential-Principles-Picture.png\" data-wpcp-wp-lb-image=\"1\"><img loading=\"lazy\" decoding=\"async\" width=\"205\" height=\"275\" src=\"http:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/07\/IMDRF-Essential-Principles-Picture.png\" alt=\"\" class=\"wp-image-2285\"\/><\/a><a href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/07\/IMDRF-Essential-Principles-Picture.png\" data-fancybox=\"wpcp-wp-img-2285\" class=\"wpcp-lightbox-trigger wpcp-advanced-image-lightbox-icon wpcp-position-top-right wpcp-advanced-image-lightbox-icon-hover wpcp-global-lightbox-icon wpcp-lightbox-icon--global wpcp-lb-icon-style-default\" data-wpcp-lb-icon-source=\"global\" aria-label=\"Open image in lightbox\" data-thumb-src=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2021\/07\/IMDRF-Essential-Principles-Picture.png\" data-wpcp-lb-single=\"1\"><span class=\"wpcp-icon-container\"><svg viewBox=\"0 0 20 20\"><path d=\"M17.6585 16.025L14.2437 12.6198C15.1716 11.3338 15.6121 9.7613 15.4871 8.1819C15.362 6.60251 14.6795 5.11847 13.5607 3.99351C12.936 3.36206 12.1916 2.86066 11.3709 2.51845C10.5502 2.17623 9.66952 2 8.77995 2C7.89039 2 7.00969 2.17623 6.18899 2.51845C5.36829 2.86066 4.62395 3.36206 3.99919 3.99351C3.36594 4.61649 2.86312 5.35871 2.51992 6.17708C2.17673 6.99545 2 7.87365 2 8.76068C2 9.64772 2.17673 10.5259 2.51992 11.3443C2.86312 12.1627 3.36594 12.9049 3.99919 13.5279C5.11957 14.6901 6.62279 15.4103 8.23285 15.5562C9.84291 15.7022 11.4517 15.2641 12.7639 14.3224L16.1788 17.7275C16.3849 17.9034 16.6473 18 16.9186 18C17.1899 18 17.4523 17.9034 17.6585 17.7275C18.1138 17.16 18.1138 16.5925 17.6585 16.025ZM5.59278 12.0523C5.16258 11.6298 4.82094 11.1263 4.58774 10.5709C4.35455 10.0156 4.23446 9.41951 4.23446 8.81744C4.23446 8.21536 4.35455 7.6193 4.58774 7.06394C4.82094 6.50859 5.16258 6.00503 5.59278 5.58257C6.01644 5.15359 6.52144 4.81292 7.07838 4.58039C7.63532 4.34786 8.23308 4.22811 8.83687 4.22811C9.44066 4.22811 10.0384 4.34786 10.5954 4.58039C11.1523 4.81292 11.6573 5.15359 12.081 5.58257C12.5112 6.00503 12.8528 6.50859 13.086 7.06394C13.3192 7.6193 13.4393 8.21536 13.4393 8.81744C13.4393 9.41951 13.3192 10.0156 13.086 10.5709C12.8528 11.1263 12.5112 11.6298 12.081 12.0523C11.6573 12.4813 11.1523 12.822 10.5954 13.0545C10.0384 13.287 9.44066 13.4068 8.83687 13.4068C8.23308 13.4068 7.63532 13.287 7.07838 13.0545C6.52144 12.822 6.01644 12.4813 5.59278 12.0523Z\" \/><\/svg><\/span><\/a><\/div><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">This document lists essential principles with internationally recognized technical standards that can be used during the design and manufacturing process to demonstrate compliance of medical devices with safety and performance requirements.<\/p>\n\n\n\n<p class=\"mb-3 wp-block-paragraph\">To read the document , click&nbsp;<a href=\"http:\/\/www.imdrf.org\/docs\/imdrf\/final\/technical\/imdrf-tech-181031-grrp-essential-principles-n47.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a>.<\/p>\n\n\n\n<section class=\"wp-block-uagb-section uagb-section__wrap uagb-section__background-undefined uagb-block-c660273d\"><div class=\"uagb-section__overlay\"><\/div><div class=\"uagb-section__inner-wrap\">\n<h3 class=\"wp-block-heading has-text-align-center mb-2 has-normal-font-size\" id=\"regulatory-coalition-principal-members\">REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n<style id=\"wp_carousel_dynamic_css118\">.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-bg{background: #0b0b0b;opacity: 0.8;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i {color: #ccc;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button .wpcp-fancybox-nav-arrow i:hover {color: #fff;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button {background: #1e1e1e;}.sp-wp-carousel-free-id-118.wpcf-fancybox-wrapper .fancybox-navigation .fancybox-button:hover {background: #1e1e1e;}#sp-wp-carousel-free-id-118 .wpcp-swiper-dots {margin: 40px 0px 0px 0px;}.wpcp-wrapper-118 .swiper-wrapper .swiper-slide-kenburn, .wpcp-wrapper-118 .swiper-wrapper, .wpcp-wrapper-118 .wpcpro-row{align-items: center;}#sp-wp-carousel-free-id-118 .wpcp-single-item {box-shadow: 0px 0px 0px 0px #dddddd;transition: all .3s;margin: 0px;}#sp-wp-carousel-free-id-118.swiper-flip .wpcp-single-item{margin: 0!important;}#sp-wp-carousel-free-id-118 .wpcp-single-item:hover {box-shadow: 0px 0px 0px 0px #dddddd;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .wpcp-single-item {border: 0px solid transparent;}#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-prev,#sp-wp-carousel-free-id-118.sp-wpcp-118 .swiper-button-next,#sp-wp-carousel-free-id-118.sp-wpcp-118 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