{"id":32879,"date":"2024-07-22T14:47:45","date_gmt":"2024-07-22T12:47:45","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/07\/22\/mdcg-2021-5-rev-1-aggiornata-guidance-on-standardisation-for-medical-devices\/"},"modified":"2024-07-22T15:15:40","modified_gmt":"2024-07-22T13:15:40","slug":"mdcg-2021-5-rev-1-aggiornata-guidance-on-standardisation-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/07\/22\/mdcg-2021-5-rev-1-aggiornata-guidance-on-standardisation-for-medical-devices\/","title":{"rendered":"MDCG 2021-5 Rev. 1: actualizaci\u00f3n de las \u00abOrientaciones sobre normalizaci\u00f3n de productos sanitarios\u00bb"},"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>El 2 de julio de 2024, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (MDCG) public\u00f3 la versi\u00f3n actualizada de la gu\u00eda <strong><em>Guidance on standardisation for medical devices<\/em> (MDCG 2021-5 Rev.1)<\/strong>, un documento de orientaci\u00f3n que tiene por objeto ofrecer orientaci\u00f3n y aclaraciones sobre diversos aspectos de las normas en el sector de los productos sanitarios, en apoyo de los requisitos establecidos en los reglamentos aplicables de la UE.<\/h2>\n<p>Los principales cambios con respecto a la edici\u00f3n anterior se resumen en <strong>forma de tabla en la p\u00e1gina 2 <\/strong>del documento.<\/p>\n<p>En primer lugar, se ha procedido a una <strong>importante actualizaci\u00f3n del marco de referencia reglamentario <\/strong>(\u00abnuevo marco legislativo\u00bb) y, en particular, se han suprimido las referencias a las antiguas Directivas, se han integrado los enlaces a los Reglamentos MDR (UE) 2017\/745, IVDR (UE) 2017\/746 y sus modificaciones, y se han a\u00f1adido las normas EN ISO 15189 e ISO 14155:2011. La actualizaci\u00f3n refleja la estrategia m\u00e1s amplia de la Uni\u00f3n Europea para racionalizar y modernizar las referencias normativas en el nuevo marco legislativo.<\/p>\n<p>Muy importante para los profesionales es la aclaraci\u00f3n del concepto de <strong>estado de la t\u00e9cnica<\/strong>, elemento crucial para mantener altos niveles de seguridad y eficacia de los productos sanitarios.<\/p>\n<p>Adem\u00e1s, aqu\u00ed est\u00e1n las <strong>principales novedades <\/strong>introducidas por la gu\u00eda:<\/p>\n<ul>\n<li>actualizaciones de las notas a pie de p\u00e1gina y los enlaces en todo el documento;<\/li>\n<li>adici\u00f3n de referencias a nuevas Comunicaciones, Directrices y un \u00abGrupo Operativo\u00bb;<\/li>\n<li>adici\u00f3n de referencias a la solicitud de normalizaci\u00f3n MDR\/IVDR y sus modificaciones;<\/li>\n<li>adici\u00f3n sobre el papel de los consultores HAS (Normas Armonizadas);<\/li>\n<li>informaci\u00f3n y aclaraciones del CEN y el CENELEC: aspectos esenciales para el cumplimiento de la normativa y de las normas de salud, rendimiento y seguridad en la industria de productos sanitarios;<\/li>\n<li>actualizaciones sobre el Foro Internacional de Reguladores de Productos Sanitarios (IMDRF);<\/li>\n<li>adici\u00f3n de una nueva secci\u00f3n (3.6) sobre las sentencias del Tribunal de Justicia de las Comunidades Europeas en materia de normalizaci\u00f3n;<\/li>\n<li>Nueva secci\u00f3n sobre la Farmacopea Europea;<\/li>\n<li>adici\u00f3n de una nueva secci\u00f3n (3.8) sobre especificaciones comunes;<\/li>\n<li>actualizaciones sobre el Foro Sectorial CEN-CENELEC sobre Normas Sanitarias (SFHS), antes conocido como ABHS.<\/li>\n<\/ul>\n<p>Como se especifica en la gu\u00eda, el <strong>contenido no es exhaustivo <\/strong>y debe leerse y utilizarse junto con el marco jur\u00eddico y las directrices sobre la legislaci\u00f3n de armonizaci\u00f3n de la UE en materia de salud, seguridad y rendimiento de los productos en el mercado interior, en particular en lo que respecta a la normalizaci\u00f3n europea. Encontrar\u00e1 m\u00e1s informaci\u00f3n sobre el marco jur\u00eddico y las directrices en las notas a pie de p\u00e1gina del documento oficial (p. 25 &#8211; 27<em>). <\/em><\/p>\n<p>El MDCG 2021 &#8211; 5 Rev. 1 es un testimonio del compromiso de la Uni\u00f3n Europea con una <strong>racionalizaci\u00f3n <\/strong>y <strong>armonizaci\u00f3n <\/strong>cada vez mayores del marco reglamentario de los productos sanitarios, en consonancia con los avances tecnol\u00f3gicos y las necesidades del mercado.<\/p>\n<p>El documento resulta exhaustivo y estrat\u00e9gico, y es probable que se convierta en una <strong>referencia autorizada <\/strong>para todos los profesionales de la industria de productos sanitarios y de asuntos reglamentarios.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>&gt;&gt; Descubra <\/strong>c\u00f3mo los <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\/\">servicios de consultor\u00eda estrat\u00e9gica de <\/a><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\/\">Thema<\/a> pueden ofrecerle un apoyo integral en el proceso de demostrar la conformidad reglamentaria de los productos sanitarios. Entre los servicios m\u00e1s populares se encuentra <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/regtodate-servizio-di-aggiornamento-normativo\/\"><strong>RegToDate<\/strong><\/a>, que le permite mantener actualizada su lista de documentos fuente externos, de acuerdo con el estado de la t\u00e9cnica y en cumplimiento de los requisitos.<\/p>\n<p><strong>Fuente:<br \/>\n<\/strong><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2021-5-rev1-guidance-standardisation-medical-devices-july-2024-2024-07-02_en\"><strong>Update &#8211; MDCG 2021-5 Rev.1 &#8211; Guidance on standardisation for medical devices &#8211; July 2024 &#8211; European Commission (europa.eu)<\/strong><\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32870,"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-32879","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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