{"id":1798,"date":"2023-05-15T13:54:12","date_gmt":"2023-05-15T13:54:12","guid":{"rendered":"https:\/\/medev.es\/?p=1798"},"modified":"2023-05-15T14:07:40","modified_gmt":"2023-05-15T14:07:40","slug":"nueva-actualizacion-mdgc-2020-3-cambios-significativos-equipos-bajo-mdd","status":"publish","type":"post","link":"https:\/\/medev.es\/?p=1798","title":{"rendered":"Nueva actualizacion MDGC 2020-3 cambios significativos equipos bajo MDD"},"content":{"rendered":"\t\t
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\ud83d\udce2 Se ha publicado una \ud835\uddee\ud835\uddf0\ud835\ude01\ud835\ude02\ud835\uddee\ud835\uddf9\ud835\uddf6\ud835\ude07\ud835\uddee\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\uddf1\ud835\uddf2 \ud835\uddf9\ud835\uddee \ud835\uddda\ud835\ude02\ud835\uddf6\u0301\ud835\uddee \ud835\udde0\ud835\uddd7\ud835\uddd6\ud835\uddda \ud835\udfee\ud835\udfec\ud835\udfee\ud835\udfec-\ud835\udfef sobre \ud835\uddf0\ud835\uddee\ud835\uddfa\ud835\uddef\ud835\uddf6\ud835\uddfc\ud835\ude00 \ud835\ude00\ud835\uddf6\ud835\uddf4\ud835\uddfb\ud835\uddf6\ud835\uddf3\ud835\uddf6\ud835\uddf0\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\ude03\ud835\uddfc\ud835\ude00 \ud835\uddf2\ud835\uddfb \ud835\uddff\ud835\uddf2\ud835\uddf9\ud835\uddee\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\uddf0\ud835\uddfc\ud835\uddfb \ud835\uddf9\ud835\uddee \ud835\uddf1\ud835\uddf6\ud835\ude00\ud835\uddfd\ud835\uddfc\ud835\ude00\ud835\uddf6\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\ude01\ud835\uddff\ud835\uddee\ud835\uddfb\ud835\ude00\ud835\uddf6\ud835\ude01\ud835\uddfc\ud835\uddff\ud835\uddf6\ud835\uddee \ud835\uddf1\ud835\uddf2\ud835\uddf9 \ud835\uddee\ud835\uddff\ud835\ude01\ud835\uddf6\u0301\ud835\uddf0\ud835\ude02\ud835\uddf9\ud835\uddfc \ud835\udfed\ud835\udfee\ud835\udfec \ud835\uddf1\ud835\uddf2\ud835\uddf9 \ud835\udde0\ud835\uddd7\ud835\udde5 para productos sanitarios certificados por MDD o AIMDD..<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\ud83d\udcc4 Esta gu\u00eda establece el marco de referencia para determinar cualquier actualizaci\u00f3n que pueden experimentar los productos \ud835\ude2d\ud835\ude26\ud835\ude28\ud835\ude22\ud835\ude24\ud835\ude3a o productos heredados, teniendo en cuenta el Reglamento 2023\/607 que establece que los productos que sigan cumpliendo con AIMDD\/MDD podr\u00e1n comercializarse o ponerse en servicio hasta el 31 de diciembre de 2027 o el 31 de diciembre de 2028, seg\u00fan proceda, siempre que se cumplan las condiciones establecidas en el art\u00edculo 120(3c).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\u2714\ufe0f productos de clase I (MDD), para los que se haya elaborado una declaraci\u00f3n CE de conformidad antes del 26 de mayo de 2021 y para los que el procedimiento de evaluaci\u00f3n de la conformidad con arreglo al MDR requiera la participaci\u00f3n de un organismo notificado;
\u2714\ufe0f productos cubiertos por un certificado CE v\u00e1lido expedido (AIMDD) o la MDD antes del 26 de mayo de 2021.

\ud83d\udd8b\ufe0f\ud83d\udd8b\ufe0fLas condiciones que se establecen en el art\u00edculo 120(3c) del MDR e incluyen, entre otras, que los productos heredados deben seguir cumpliendo con AIMDD\/MDD, seg\u00fan proceda, y que no se produzcan cambios significativos en el dise\u00f1o o la finalidad prevista del producto.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Puedes obtener esta gu\u00eda aqu\u00ed \"\ud83d\udc49\"<\/p>

https:\/\/health.ec.europa.eu\/system\/files\/2023-05\/mdcg_2020-3_en.pdf<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Se ha publicado una \ud835\uddee\ud835\uddf0\ud835\ude01\ud835\ude02\ud835\uddee\ud835\uddf9\ud835\uddf6\ud835\ude07\ud835\uddee\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\uddf1\ud835\uddf2 \ud835\uddf9\ud835\uddee \ud835\uddda\ud835\ude02\ud835\uddf6\u0301\ud835\uddee \ud835\udde0\ud835\uddd7\ud835\uddd6\ud835\uddda \ud835\udfee\ud835\udfec\ud835\udfee\ud835\udfec-\ud835\udfef sobre \ud835\uddf0\ud835\uddee\ud835\uddfa\ud835\uddef\ud835\uddf6\ud835\uddfc\ud835\ude00 \ud835\ude00\ud835\uddf6\ud835\uddf4\ud835\uddfb\ud835\uddf6\ud835\uddf3\ud835\uddf6\ud835\uddf0\ud835\uddee\ud835\ude01\ud835\uddf6\ud835\ude03\ud835\uddfc\ud835\ude00 \ud835\uddf2\ud835\uddfb \ud835\uddff\ud835\uddf2\ud835\uddf9\ud835\uddee\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\uddf0\ud835\uddfc\ud835\uddfb \ud835\uddf9\ud835\uddee \ud835\uddf1\ud835\uddf6\ud835\ude00\ud835\uddfd\ud835\uddfc\ud835\ude00\ud835\uddf6\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\ude01\ud835\uddff\ud835\uddee\ud835\uddfb\ud835\ude00\ud835\uddf6\ud835\ude01\ud835\uddfc\ud835\uddff\ud835\uddf6\ud835\uddee \ud835\uddf1\ud835\uddf2\ud835\uddf9 \ud835\uddee\ud835\uddff\ud835\ude01\ud835\uddf6\u0301\ud835\uddf0\ud835\ude02\ud835\uddf9\ud835\uddfc \ud835\udfed\ud835\udfee\ud835\udfec \ud835\uddf1\ud835\uddf2\ud835\uddf9 \ud835\udde0\ud835\uddd7\ud835\udde5 para productos sanitarios certificados por MDD o AIMDD.<\/p>\n","protected":false},"author":1,"featured_media":1804,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1798","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mdd"],"yoast_head":"\nNueva actualizacion MDGC 2020-3 cambios significativos equipos bajo MDD - MeDev<\/title>\n<meta name=\"description\" content=\"Se ha publicado una \ud835\uddee\ud835\uddf0\ud835\ude01\ud835\ude02\ud835\uddee\ud835\uddf9\ud835\uddf6\ud835\ude07\ud835\uddee\ud835\uddf0\ud835\uddf6\ud835\uddfc\u0301\ud835\uddfb \ud835\uddf1\ud835\uddf2 \ud835\uddf9\ud835\uddee \ud835\uddda\ud835\ude02\ud835\uddf6\u0301\ud835\uddee 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