{"id":22893,"date":"2022-08-10T17:08:42","date_gmt":"2022-08-10T15:08:42","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=22893"},"modified":"2022-08-10T17:10:42","modified_gmt":"2022-08-10T15:10:42","slug":"reino-unido-posible-ampliacion-de-la-validez-del-marcado-ce","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/08\/10\/reino-unido-posible-ampliacion-de-la-validez-del-marcado-ce\/","title":{"rendered":"Reino Unido: posible ampliaci\u00f3n de la validez del marcado CE"},"content":{"rendered":"<p>Con el fin de evitar un bloqueo de los suministros sanitarios en el territorio, la Agencia Reguladora de Medicamentos y Productos Sanitarios (MHRA<em>, Medicines and Healthcare products Regulatory Agency<\/em>) est\u00e1 evaluando la posibilidad de ampliar el marcado UKCA en determinadas condiciones inevitables.<\/p>\n<p>El escenario propuesto como resultado de esta evaluaci\u00f3n modificar\u00eda lo ya publicado en la directriz <a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\"><em>Regulating medical devices in the UK<\/em><\/a> actualizada el pasado mes de enero, que establec\u00eda el 30 de junio de 2023 como fecha l\u00edmite y obligatoria para colocar la marca UKCA.<\/p>\n<p>Tal y como se recoge en la respuesta del Gobierno <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1085333\/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf\"><em>Government response to consultation on the future regulation of medical devices in the United Kingdom<\/em><\/a>, actualizada el 26 de junio, la MHRA expresa la posibilidad de permitir que los dispositivos que ya tengan el marcado CE permanezcan en el mercado brit\u00e1nico despu\u00e9s del <strong>30 de junio de 2023<\/strong>. Esta pr\u00f3rroga depender\u00eda de la expiraci\u00f3n del certificado o de un plazo definido, es decir, 3 a\u00f1os (para los Dispositivos M\u00e9dicos) y 5 a\u00f1os (para los DIV).<\/p>\n<p>En detalle, la ampliaci\u00f3n ser\u00eda la siguiente:<\/p>\n<ul>\n<li>Dispositivos con marcado CE en periodo de gracia de acuerdo con la MDD, AIMDD e IVDD: comercializables durante 3-5 a\u00f1os a partir del 01\/07\/2023;<\/li>\n<li>Dispositivos con marcado CE que cumplen con el MDR y el IVDR: comercializables durante 3-5 a\u00f1os o hasta la expiraci\u00f3n del certificado de la UE, lo que ocurra antes.<\/li>\n<\/ul>\n<p>No obstante, ser\u00eda posible beneficiarse de esta pr\u00f3rroga si se cumplen determinadas condiciones durante el periodo transitorio, en particular:<\/p>\n<ul>\n<li>la ausencia de cambios significativos en el dise\u00f1o o el uso previsto del dispositivo;<\/li>\n<li>el pleno cumplimiento de los requisitos de vigilancia postcomercializaci\u00f3n definidos por la normativa brit\u00e1nica;<\/li>\n<li>que el certificado y la declaraci\u00f3n de conformidad han sido emitidos antes del 30\/06\/2023;<\/li>\n<li>que los dispositivos se comercializaron antes del 30\/06\/2023 cumpliendo con los requisitos legislativos y reglamentarios del Reino Unido, especialmente en lo que respecta al registro en la MHRA.<\/li>\n<\/ul>\n<p>Por otro lado, no existe ning\u00fan problema de libre circulaci\u00f3n en el territorio del Reino Unido para los dispositivos que ya cuentan con la marca UKCA desde el 1 de julio de 2023.<\/p>\n<p>Si se ratifica, esto supondr\u00eda <strong>un claro beneficio para todos los fabricantes de Dispositivos M\u00e9dicos y de IVDs que no sean del Reino Unido<\/strong>, proporcionando una \u00fatil extensi\u00f3n de tiempo para que los Organismos Notificados designados obtengan un certificado UKCA, que hoy en d\u00eda siguen siendo insuficientes en n\u00famero para cumplir con los requisitos del mercado y de la salud.<\/p>\n<p><em>Fuente:<\/em> <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1085333\/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf\"><em>Government response to consultation on the future regulation of medical devices in the United Kingdom<\/em><\/a><\/p>\n<p>&gt;&gt; Conf\u00ede en <strong>Thema<\/strong> para el <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-de-uk-responsible-person-uk-rp\/\">servicio UKRP<\/a> necesario para cumplir los requisitos reglamentarios de los dispositivos que se comercializan en el Reino Unido.<\/p>\n<p>\u00bfQuiere saber m\u00e1s? Ir a la <a href=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/08\/UKRP_ES.pdf\">pagina de servicios del UKRP<\/a><\/p>\n<p>&gt;&gt;&gt; Si necesita m\u00e1s informaci\u00f3n sobre la normativa t\u00e9cnica o el apoyo estrat\u00e9gico de nuestros expertos del Reino Unido, <a href=\"mailto:sales@thema-med.com\">contacta nuestro Customer Service<\/a>.<\/p>\n<p>&gt;&gt; Mant\u00e9ngase al d\u00eda de los requisitos previos a la comercializaci\u00f3n de dispositivos en el Reino Unido y <a href=\"https:\/\/www.thema-med.com\/es\/biblioteca\/brexit-news-esp\/\">suscr\u00edbase a Brexit News<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Con el fin de evitar un bloqueo de los suministros sanitarios en el territorio, la Agencia Reguladora de Medicamentos y Productos  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":22870,"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-22893","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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