{"id":27698,"date":"2023-05-11T10:35:34","date_gmt":"2023-05-11T08:35:34","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=27698"},"modified":"2023-05-09T16:48:07","modified_gmt":"2023-05-09T14:48:07","slug":"reino-unido-suiza-impacto-de-la-ampliacion-del-mdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/05\/11\/reino-unido-suiza-impacto-de-la-ampliacion-del-mdr\/","title":{"rendered":"REINO UNIDO\/SUIZA: impacto de la ampliaci\u00f3n del MDR"},"content":{"rendered":"<h2>Los d\u00edas 28 y 29 de marzo de 2023, <strong>los Gobiernos brit\u00e1nico<\/strong> y <strong>suizo<\/strong> anunciaron que <strong>el per\u00edodo de pr\u00f3rroga<\/strong> en la forma establecida en el <strong>Reglamento (UE) 2023\/607<\/strong> del <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv%3AOJ.L_.2023.080.01.0024.01.ENG&amp;toc=OJ%3AL%3A2023%3A080%3ATOC\"><em>Parlamento Europeo y del Consejo, de 15 de marzo de 2023, por el que se modifican los Reglamentos (UE) 2017\/745 y (UE) 2017\/746 en lo que respecta a las disposiciones transitorias para determinados productos sanitarios y productos sanitarios para diagn\u00f3stico in vitro<\/em><\/a>, tambi\u00e9n se aplicar\u00e1 en sus territorios, una medida que formaliza y hace inmediatamente exigible en Europa el tercer per\u00edodo transitorio para el cumplimiento del MDR (UE) 2017\/745.<\/h2>\n<p>Por tanto, ser\u00e1 posible comercializar productos sanitarios con <strong>marcado CE<\/strong> en el <strong>Reino Unido<\/strong> y <strong>Suiza<\/strong> dentro de los plazos establecidos por el <strong>Reglamento (UE) 2023\/607: hasta el 31 de diciembre de 2027 o hasta el 31 de diciembre de 2028,<\/strong> dependiendo de la clase de riesgo y del tipo de producto.<\/p>\n<p>En consecuencia, el <strong>Ministerio de Sanidad brit\u00e1nico (MHRA)<\/strong> ha anunciado que se actualizar\u00e1 la directriz <a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\"><strong>Regulating medical devices in the UK<\/strong><\/a> (Regulaci\u00f3n de los productos sanitarios en el Reino Unido) para adaptarla a esta medida.<\/p>\n<p>Del mismo modo, <strong>Swissmedic<\/strong> est\u00e1 planeando un ajuste correspondiente de la Ordenanza sobre MDs (<a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/en\"><strong>ODmed<\/strong><\/a>) de 1 de julio de 2020 y la Ordenanza sobre IVDs (<a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2022\/291\/en\"><strong>ODIV<\/strong><\/a>) de 4 de mayo de 2022 para <strong>el oto\u00f1o de 2023.<\/strong><\/p>\n<p>Con estas disposiciones, las <strong>autoridades reguladoras del Reino Unido y Suiza<\/strong>, as\u00ed como el legislador europeo, quer\u00edan <strong>evitar una posible escasez de productos sanitarios disponibles en el mercado<\/strong>, dando a los fabricantes establecidos fuera de sus territorios m\u00e1s tiempo para llevar a cabo todos los procedimientos necesarios para cumplir sus obligaciones reglamentarias.<\/p>\n<p>&gt;&gt; Si desea comercializar productos sanitarios en el Reino Unido y Suiza, Thema puede ayudarle con el servicio de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\"><strong>consulencia estrat\u00e9gico-regulatoria<\/strong><\/a>, puede ser su <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-uk-responsible-person-uk-rp\/\"><strong>UK Responsible Person (UKRP)<\/strong><\/a> y su <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/representante-autorizado-suizo\/\"><strong>Representante autorizado suizo (CH REP)<\/strong><\/a> y puede ayudarle a registrar los productos ante las autoridades reguladoras.<\/p>\n<h3>Mant\u00e9ngase informado sobre la normativa vigente en materia de productos sanitarios en el Reino Unido y Suiza: \u00a1suscr\u00edbase al <a href=\"https:\/\/www.thema-med.com\/es\/newsletter-3\/\">bolet\u00edn de Thema<\/a>!<\/h3>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\">P\u00f3ngase en contacto con nosotros.<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>Fuentes:<\/p>\n<p><a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/market-access\/abgelaufene_bescheinigungen.html\">https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/market-access\/abgelaufene_bescheinigungen.html<\/a><\/p>\n<p><a href=\"https:\/\/www.admin.ch\/gov\/en\/start\/documentation\/media-releases.msg-id-94011.html\">https:\/\/www.admin.ch\/gov\/en\/start\/documentation\/media-releases.msg-id-94011.html<\/a><\/p>\n<p><a href=\"https:\/\/www.gov.uk\/government\/news\/extension-of-ce-certificates\">https:\/\/www.gov.uk\/government\/news\/extension-of-ce-certificates<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Los d\u00edas 28 y 29 de marzo de 2023, los Gobiernos brit\u00e1nico y suizo anunciaron que el per\u00edodo de pr\u00f3rroga en  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":27789,"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-27698","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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>REINO UNIDO\/SUIZA: impacto de la ampliaci\u00f3n del MDR - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"description\" content=\"Los d\u00edas 28 y 29 de marzo de 2023, los Gobiernos brit\u00e1nico y suizo anunciaron que el per\u00edodo de pr\u00f3rroga en la forma 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