{"id":7727,"date":"2018-08-08T09:38:22","date_gmt":"2018-08-08T07:38:22","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7727"},"modified":"2023-01-24T15:05:23","modified_gmt":"2023-01-24T14:05:23","slug":"ue-instrucciones-utiles-para-fabricantes-de-dm-ivd","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/08\/08\/ue-instrucciones-utiles-para-fabricantes-de-dm-ivd\/","title":{"rendered":"UE: Instrucciones \u00fatiles para fabricantes de DM e IVD"},"content":{"rendered":"<p><img decoding=\"async\" class=\"size-medium wp-image-7764 alignnone\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/08\/EU-Commission-300x169.jpg\" alt=\"\" width=\"300\" height=\"169\" \/><\/p>\n<p>Si usted es un fabricante, un Representante Autorizado, un importador o un distribuidor, lo m\u00e1s probable es que necesite recibir m\u00e1s instrucciones de la Uni\u00f3n Europea sobre la implementaci\u00f3n de los Reglamentos MDR (UE) 2017\/745 e IVDR (UE) 2017\/746 que entraron en vigor el 26 de mayo de 2017.<\/p>\n<p>Dado que los periodos de transici\u00f3n de estos Reglamentos est\u00e1n a punto de finalizar, la Comisi\u00f3n Europea en colaboraci\u00f3n con el Medical Device Coordination Group (MDCG) emiti\u00f3 cinco Directrices para apoyar a los operadores econ\u00f3micos.<\/p>\n<p>Los documentos antes mencionados se muestran a continuaci\u00f3n:<\/p>\n<ul>\n<li>Una lista de verificaci\u00f3n centrata en las obligaciones del fabricante seg\u00fan el MDR (EU) 2017\/745 y el IVDR (UE) 2017\/746:<\/li>\n<\/ul>\n<p><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/30961?locale=en\">Exhaustive list of requirements for manufacturers of medical devices<\/a><\/p>\n<ul>\n<li>Instrucciones paso a paso para los dispositivos m\u00e9dicos e IVD que describen las actividades que se realizar\u00e1n para facilitar la implementaci\u00f3n de los dos Reglamentos:<\/li>\n<\/ul>\n<p><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/30905?locale=en\">Step by step implementation model for medical devices Regulation<\/a><\/p>\n<p><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/30907?locale=en\">Step by step implementation model for in-vitro diagnostic medical devices Regulation<\/a><\/p>\n<ul>\n<li>Hojas de datos para los fabricantes de dispositivos m\u00e9dicos e IVD que proporcionan una visi\u00f3n general de los cambios y los plazos de implementaci\u00f3n de\u00a0los Reglamentos:<\/li>\n<\/ul>\n<p><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/31162?locale=en\">Factsheet for manufacturers of in-vitro diagnostic medical devices<\/a><\/p>\n<p><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/31161?locale=en\">Factsheet for manufacturers of medical devices<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>Para m\u00e1s informaci\u00f3n:<\/p>\n<p><a href=\"http:\/\/ec.europa.eu\/docsroom\/documents?keywords=medical%20device&amp;locale=en&amp;page=1&amp;pageSize=10\" target=\"_blank\" rel=\"noopener\">European Commission<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Si usted es un fabricante, un Representante Autorizado, un importador o un distribuidor, lo m\u00e1s probable es que necesite recibir m\u00e1s  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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-7727","post","type-post","status-publish","format-standard","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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