{"id":8700,"date":"2019-01-18T13:48:40","date_gmt":"2019-01-18T12:48:40","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8700"},"modified":"2023-01-26T12:22:43","modified_gmt":"2023-01-26T11:22:43","slug":"union-europea-que-significa-brexit-no-deal-para-los-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/01\/18\/union-europea-que-significa-brexit-no-deal-para-los-dispositivos-medicos\/","title":{"rendered":"UNI\u00d3N EUROPEA: \u00bfqu\u00e9 significa Brexit \u00abno deal\u00bb para los dispositivos m\u00e9dicos?"},"content":{"rendered":"<p>Para ayudar a stakeholders a abordar mejor el \u201cno-deal\u201d Brexit, el 3 de enero de 2019, la Agencia Regulatoria de\u00a0Medicamentos\u00a0y\u00a0Productos\u00a0para\u00a0el\u00a0Cuidado de la\u00a0Salud (MHRA) del Reino Unido <a href=\"https:\/\/www.gov.uk\/government\/publications\/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal?utm_source=9176436c-0dba-47af-9a94-d50f97e737da&amp;utm_medium=email&amp;utm_campaign=govuk-notifications&amp;utm_content=immediate\">public\u00f3 una gu\u00eda<\/a> que contiene las disposiciones propuestas para la regulaci\u00f3n de medicamentos, dispositivos m\u00e9dicos e investigaciones cl\u00ednicas.<\/p>\n<p>El 15 de enero de 2019, el Parlamento brit\u00e1nico se neg\u00f3 a rechazar el acuerdo para la salida del Reino Unido por parte de la Uni\u00f3n Europea firmado en noviembre pasado entre el Primer Ministro May y los l\u00edderes de los 27 Estados miembros de la UE. <strong>En ausencia<\/strong> de un acuerdo econ\u00f3mico, el Reino Unido se convierte en el tercer pa\u00eds frente a la UE y MHRA asume la regulaci\u00f3n de dispositivos m\u00e9dicos, medicamentos e investigaciones cl\u00ednicas actualmente reguladas por la UE.<\/p>\n<p>En particular, a partir del 29 de marzo de 2019 (fecha Brexit), <a href=\"https:\/\/www.gov.uk\/government\/publications\/submitting-regulatory-information-on-medical-products-if-theres-no-brexit-deal\/submitting-regulatory-information-on-medical-products-if-theres-no-brexit-deal\">MHRA solicitar\u00e1 el registro<\/a> de todos los dispositivos m\u00e9dicos, dispositivos m\u00e9dicos activos implantables, IVD y dispositivos personalizados antes de ser colocados en el mercado brit\u00e1nico.<\/p>\n<p>Otras disposiciones del plan \u00abB\u00bb (o \u00abBrexit\u00bb sin acuerdo) se refieren:<\/p>\n<ul>\n<li>otorgar un \u00abper\u00edodo de gracia\u00bb a los fabricantes para registrar sus dispositivos en MHRA y para cumplir con los nuevos requisitos, como la introducci\u00f3n del c\u00f3digo GMDN (Global Medical Device Nomenclature)\u00a0y el nombramiento de la <strong>Persona Responsable en el Reino Unido<\/strong> (similar al Representante Europea) en el caso de fabricantes extranjeros;<\/li>\n<li>conformidad del producto: MHRA continuar\u00e1 reconociendo la validez de los certificados emitidos por los organismos notificados establecidos en el Reino Unido antes de Brexit (29 de marzo de 2019);<\/li>\n<li>regulaci\u00f3n de las investigaciones cl\u00ednicas;<\/li>\n<li>vigilancia del mercado de dispositivos e<\/li>\n<li>implementaci\u00f3n de MDR y IVDR en el Reino Unido simult\u00e1neamente con la implementaci\u00f3n en la UE.<\/li>\n<\/ul>\n<p>El 19 de diciembre de 2018, la Comisi\u00f3n Europea tambi\u00e9n public\u00f3 su propio <a href=\"https:\/\/ec.europa.eu\/info\/sites\/info\/files\/com-2018-890-final.pdf\">plan de acci\u00f3n Brexit \u00absin acuerdo\u00bb<\/a> e inst\u00f3 a los Estados miembros de la UE a no celebrar acuerdos bilaterales con el Reino Unido. Poco despu\u00e9s de la conclusi\u00f3n de la votaci\u00f3n, el presidente de la Comisi\u00f3n Europea inst\u00f3 al Reino Unido a aclarar sus intenciones pol\u00edticas y econ\u00f3micas lo antes posible.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Para ayudar a stakeholders a abordar mejor el \u201cno-deal\u201d Brexit, el 3 de enero de 2019, la Agencia Regulatoria de\u00a0Medicamentos\u00a0y\u00a0Productos\u00a0para\u00a0el\u00a0Cuidado de  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":22413,"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":[1570,3],"tags":[],"class_list":["post-8700","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-brexit-esp","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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