{"id":32630,"date":"2024-05-27T10:35:41","date_gmt":"2024-05-27T08:35:41","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/05\/27\/imdrf-pubblicata-guida-sui-principi-di-sicurezza-e-prestazione-dei-dispositivi-medici\/"},"modified":"2024-05-28T09:54:57","modified_gmt":"2024-05-28T07:54:57","slug":"imdrf-pubblicata-guida-sui-principi-di-sicurezza-e-prestazione-dei-dispositivi-medici","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/05\/27\/imdrf-pubblicata-guida-sui-principi-di-sicurezza-e-prestazione-dei-dispositivi-medici\/","title":{"rendered":"IMDRF: publicadas orientaciones sobre los principios de seguridad y funcionamiento de los productos sanitarios"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2><\/h2>\n<h2>El 26 de abril de 2024, el <strong>International Medical Device Regulation Forum (IMDRF) <\/strong>public\u00f3 <a href=\"https:\/\/www.imdrf.org\/sites\/default\/files\/2024-04\/IMDRF%20GRRP%20WG%20N47%20%28Edition%202%29.pdf\"><strong>\u201cEssential Principles of Safety and Performance of Medical Devices and IVD Medical Devices<\/strong>\u201d<\/a>, el documento que establece los principios esenciales armonizados que deben observarse en el dise\u00f1o y la fabricaci\u00f3n de productos sanitarios y productos para diagn\u00f3stico in vitro con el fin de garantizar la seguridad y la eficacia de los productos de acuerdo con su uso previsto.<\/h2>\n<p>La <strong>adopci\u00f3n mundial <\/strong>de un conjunto de principios que tocan aspectos fundamentales de la fabricaci\u00f3n de dispositivos refleja plenamente la misi\u00f3n del <strong>IMDRF<\/strong>, que re\u00fane desde 2011 a autoridades reguladoras de diferentes jurisdicciones de todo el mundo para promover la convergencia normativa en el sector a nivel mundial.<\/p>\n<p>Entre las principales \u00e1reas de inter\u00e9s se encuentra el <strong>proceso de<\/strong> <strong>gesti\u00f3n de riesgos<\/strong>, fundamental a lo largo de todo el ciclo de vida del producto. Tambi\u00e9n se ocupa del proceso de <strong>evaluaci\u00f3n cl\u00ednica<\/strong>, que, cuando se requiera, debe ser capaz de demostrar adecuadamente la relaci\u00f3n riesgo-beneficio del producto bas\u00e1ndose en informes de investigaciones cl\u00ednicas, publicaciones cient\u00edficas, experiencias cl\u00ednicas.<\/p>\n<p>En particular, se destaca la importancia de las <strong>propiedades qu\u00edmicas, f\u00edsicas y biol\u00f3gicas de un dispositivo<\/strong>, y se hace hincapi\u00e9 en que debe prestarse especial atenci\u00f3n a la <strong>toxicidad, la biocompatibilidad y la inflamabilidad<\/strong> a la hora de elegir materiales y sustancias.<strong>\u00a0 <\/strong>Una secci\u00f3n de la directriz se dedica espec\u00edficamente a orientar sobre la <strong>protecci\u00f3n frente a riesgos el\u00e9ctricos, mec\u00e1nicos y t\u00e9rmicos<\/strong>.<\/p>\n<p>A continuaci\u00f3n, se tratan en detalle los aspectos que deben tenerse en cuenta en el <strong>proceso de esterilizaci\u00f3n y contaminaci\u00f3n biol\u00f3gica<\/strong>, estableciendo, por ejemplo, que los productos deben dise\u00f1arse directamente con vistas a facilitar su limpieza y desinfecci\u00f3n, a fin de proteger la seguridad de los usuarios.<\/p>\n<p>En el <strong>ap\u00e9ndice <\/strong>\ud835\uddd4 se expone el planteamiento general del uso de normas para la evaluaci\u00f3n de la conformidad de un producto, y en el <strong>ap\u00e9ndice<\/strong> <strong>B<\/strong> se relacionan en una tabla los principios expuestos con las directrices disponibles y las normas aplicables internacionalmente.<\/p>\n<p>La adhesi\u00f3n mundial a un conjunto com\u00fan de principios de dise\u00f1o y fabricaci\u00f3n no s\u00f3lo proporciona garant\u00edas de eficacia y seguridad, sino que tambi\u00e9n ofrece importantes ventajas a fabricantes, usuarios, pacientes y organismos reguladores. La <strong>reducci\u00f3n de las diferencias entre jurisdicciones <\/strong>disminuye el tiempo y el coste para lograr el cumplimiento y permite a los pacientes acceder antes a las nuevas tecnolog\u00edas y tratamientos.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>&gt;&gt;&gt;&gt;<\/strong> A trav\u00e9s de sus servicios de <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>Consultor\u00eda estrat\u00e9gica-regulatoria<\/strong><\/a>, Thema puede ayudarle a cumplir los requisitos regulatorios para acceder a los mercados europeos e internacionales, con actividades como el\u00a0 <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/supporto-alla-certificazione-ce-dispositivi-medici-ivd\/\"><strong>apoyo en la obtenci\u00f3n del marcado CE para productos sanitarios y de diagn\u00f3stico in vitro<\/strong><\/a>, <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><strong>registros internacionales extracomunitarios de productos sanitarios y de diagn\u00f3stico in vitro ante Autoridades Reguladoras extranjeras<\/strong>. <\/a>Las propuestas tambi\u00e9n incluyen <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/qualita-e-gmp-internazionali\/\"><strong>asistencia para la implantaci\u00f3n de sistemas de calidad para productos sanitarios y buenas pr\u00e1cticas de fabricaci\u00f3n (BPF) <\/strong><\/a>.<\/p>\n<p><strong>Fuente<\/strong><strong>:<br \/>\n<\/strong><a href=\"https:\/\/www.imdrf.org\/sites\/default\/files\/2024-04\/IMDRF%20GRRP%20WG%20N47%20%28Edition%202%29.pdf\"><strong>\u201cEssential Principles of Safety and Performance of Medical Devices and IVD Medical Devices\u201d<\/strong><\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32607,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-32630","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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