{"id":28478,"date":"2023-07-07T10:59:51","date_gmt":"2023-07-07T08:59:51","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=28478"},"modified":"2023-08-04T12:12:43","modified_gmt":"2023-08-04T10:12:43","slug":"reino-unido-la-mhra-amplia-la-validez-del-marcado-ce","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2023\/07\/07\/reino-unido-la-mhra-amplia-la-validez-del-marcado-ce\/","title":{"rendered":"REINO UNIDO: la MHRA ampl\u00eda la validez del marcado CE"},"content":{"rendered":"<h2>La Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA) ha ampliado el plazo de aceptaci\u00f3n en el Reino Unido de los productos sanitarios y de diagn\u00f3stico in vitro que llevan la marca CE, con el fin de garantizar la seguridad del suministro de estos productos en el pa\u00eds.<\/h2>\n<p>El 14 de junio, la MHRA public\u00f3 el <a href=\"https:\/\/www.legislation.gov.uk\/uksi\/2023\/627\/pdfs\/uksi_20230627_en.pdf\"><strong><em>Statutory Instrument 2023 No. 627 \u00abMedical Devices (Amendment) (Great Britain) Regulations 2023<\/em><\/strong><\/a> por el que decidi\u00f3 ampliar el periodo de colocaci\u00f3n de los productos sanitarios y los IVD con marcado CE.<\/p>\n<p>En concreto, los productos sanitarios con marcado CE pueden seguir comercializ\u00e1ndose con arreglo a distintos plazos, a saber:<\/p>\n<p>&#8211; Dispositivos implantables de clase III y clase IIb hasta el <strong>31\/12\/2027<\/strong>;<\/p>\n<p>&#8211; dispositivos de clase IIb, clase IIa, clase Is, Im e Ir hasta el <strong>30\/06\/2028<\/strong>;<\/p>\n<p>&#8211; dispositivos autocertificados MDD de clase I, reclasificados por MDR, hasta el <strong>30\/06\/2028<\/strong>.<\/p>\n<p>En el caso de los productos IVD con marcado CE, la comercializaci\u00f3n puede continuar del siguiente modo:<\/p>\n<p>&#8211; autodeclaraci\u00f3n y dispositivos de clase D hasta <strong>el 26\/05\/2025;<\/strong><\/p>\n<p>&#8211; productos de la clase C hasta el <strong>26\/05\/2026;<\/strong><\/p>\n<p>&#8211; productos est\u00e9riles de las clases B y A hasta el <strong>26\/05\/2027.<\/strong><\/p>\n<p>Por lo tanto, como ya se ha mencionado, con el fin de garantizar la presencia de dispositivos dentro de las instalaciones sanitarias del pa\u00eds, la Autoridad Reguladora del Reino Unido ha ampliado el plazo para la aceptaci\u00f3n de dispositivos m\u00e9dicos y IVDs, pero tambi\u00e9n ha declarado que tiene la intenci\u00f3n de revisar y actualizar su normativa a partir del <strong>01\/07\/2025<\/strong>. No es probable que esta \u00faltima se desv\u00ede significativamente de la normativa europea, ya que los procesos y normas de evaluaci\u00f3n de la conformidad que se utilizar\u00e1n para demostrar la conformidad con la <strong>marca UKCA<\/strong> ser\u00e1n pr\u00e1cticamente los mismos que los aplicables a la marca CE.<\/p>\n<p>&gt;&gt; Si desea comercializar productos sanitarios e IVD en el Reino Unido, Thema puede ayudarle con el <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\"><strong>Servicio de 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 puede ayudarle a <strong>registrar productos<\/strong> en la MHRA.<\/p>\n<p><strong>Fuentes<\/strong><\/p>\n<p><a href=\"https:\/\/www.legislation.gov.uk\/uksi\/2023\/627\/pdfs\/uksi_20230627_en.pdf\">The Medical Devices (Amendment) (Great Britain) Regulations 2023<\/a><\/p>\n<p><a href=\"https:\/\/www.gov.uk\/government\/publications\/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period#full-publication-update-history\">Implementation of medical devices future regime<\/a><\/p>\n<p><a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1166483\/Infographic_-_Devices_transition_timeline.pdf\">Timelines for placing CE marked IVDs on the Great Britain market<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA) ha ampliado el plazo de aceptaci\u00f3n en el Reino Unido de los  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":28502,"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-28478","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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