{"id":29796,"date":"2023-08-02T11:55:03","date_gmt":"2023-08-02T09:55:03","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=29796"},"modified":"2023-08-04T12:09:39","modified_gmt":"2023-08-04T10:09:39","slug":"reino-unido-se-publica-una-plantilla-para-la-alineacion-de-la-ampliacion-del-mdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/08\/02\/reino-unido-se-publica-una-plantilla-para-la-alineacion-de-la-ampliacion-del-mdr\/","title":{"rendered":"Reino Unido: se publica una plantilla para la alineaci\u00f3n de la ampliaci\u00f3n del MDR"},"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-blend:overlay;--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 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">El 3 de julio de 2023, la Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA) public\u00f3 en su sitio web oficial <em><a href=\"https:\/\/www.thema-med.com\/es\/contactanos\/\">la confirmaci\u00f3n de extensi\u00f3n del art\u00edculo 120 del MDR de la UE<\/a><\/em>, una <strong>plantilla<\/strong> de la carta que deben presentar los Fabricantes para alinearse con el art\u00edculo 120 del Reglamento MDR (UE) 2017\/745.<\/h2>\n<p>Este documento no es una directriz, sino una declaraci\u00f3n del fabricante: \u00e9ste debe rellenar el formulario indicando en qu\u00e9 condiciones puede beneficiarse de la pr\u00f3rroga.<\/p>\n<p>A continuaci\u00f3n se recuerdan las <strong>condiciones<\/strong> que deben cumplirse para la pr\u00f3rroga de la validez de un certificado CE en virtud del art\u00edculo 120 y que permiten comercializar el producto en el Reino Unido.<\/p>\n<ul>\n<li>En el caso de los certificados que expiraron antes del 20\/03\/2023, el fabricante tiene un <strong>contrato firmado<\/strong> con un Organismo Notificado anterior a la expiraci\u00f3n original del certificado;<\/li>\n<li>En el caso de los certificados que hayan expirado antes del 20\/03\/2023 y cuando no se haya firmado ning\u00fan contrato entre el fabricante y el Organismo Notificado, el primero podr\u00e1 beneficiarse de la pr\u00f3rroga si:\n<ul>\n<li>recibe una exenci\u00f3n de los procedimientos de evaluaci\u00f3n de la conformidad en virtud del <strong>art\u00edculo 59<\/strong> del MDR, o<\/li>\n<li>se lleve a cabo la evaluaci\u00f3n de la conformidad con arreglo al <strong>art\u00edculo 97<\/strong> del MDR.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&gt;&gt;&gt; Si desea comercializar productos sanitarios e IVD en el Reino Unido, Thema puede ayudarle con el Servicio de <strong><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">Consulencia Estrat\u00e9gico-Reguladora<\/a><\/strong>, ser designado <strong><a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-uk-responsible-person-uk-rp\/\">Persona Responsable en el Reino Unido (UKRP)<\/a><\/strong> de la organizaci\u00f3n y apoyarle en el <strong>registro de productos<\/strong> ante la MHRA.<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/lnkd.in\/d9QvBRYG\">EU MDR Article 120 extension confirmation<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":29791,"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-29796","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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