{"id":1305,"date":"2023-03-20T08:03:13","date_gmt":"2023-03-20T08:03:13","guid":{"rendered":"https:\/\/medev.es\/?p=1305"},"modified":"2023-03-20T10:48:08","modified_gmt":"2023-03-20T10:48:08","slug":"reglamento-ue-2023-607","status":"publish","type":"post","link":"https:\/\/medev.es\/?p=1305","title":{"rendered":"Ampliaci\u00f3n plazo validez Directiva MDD"},"content":{"rendered":"\t\t
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Ha entrado en vigor el REGLAMENTO (UE) 2023\/607 prorrogando la validez de los certificados expedidos de conformidad con las Directivas 90\/385\/CEE y 93\/42\/CEE.

Clase III 12\/2027, resto 12\/2028 
EUR-Lex - 52023PC0010 - EN - EUR-Lex (europa.eu)<\/a><\/h2>\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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Todos los certificados expedidos por organismos notificados de conformidad con dichas Directivas a partir del 25\/05\/2017 que a\u00fan fueran v\u00e1lidos el 26\/05\/2021, que no se hayan retirado en fecha posterior seguir\u00e1n siendo v\u00e1lidos hasta:<\/p>

\u2705 31\/12\/2027, para todos los productos de la clase III y para los productos implantables de la clase IIb, excepto material de sutura, grapas, materiales para obturaci\u00f3n dental, aparatos de ortodoncia, coronas dentales, tornillos, cu\u00f1as, placas, cables, alfileres, clips y dispositivos de conexi\u00f3n;
\u2705 31\/12\/2028, para los productos de la clase IIb distintos de los contemplados en el apartado anterior, para los productos de la clase IIa, y para los productos de la clase I introducidos en el mercado en condiciones est\u00e9riles o que tengan una funci\u00f3n de medici\u00f3n.<\/p>

\u2705 26\/05\/2026, para los productos a medida implantables de la clase III<\/p>

Podr\u00e1n seguir siendo comercializados o puestos en servicio los productos introducidos legalmente en el mercado de conformidad con:
\u2705 las Directivas 90\/385\/CEE y 93\/42\/CEE, antes del 26 de mayo de 2021
\u2705 la Directiva 98\/79\/CE, antes del 26 de mayo de 2022.<\/p>

Los certificados expedidos por organismos notificados de conformidad con dichas Directivas a partir del 25\/05\/2017 que a\u00fan fueran v\u00e1lidos el 26\/05\/2021, y que hayan expirado antes del 20\/03\/2023, se considerar\u00e1n v\u00e1lidos bajo determinadas condiciones.<\/p>

Esta nueva prorroga supone un tiempo muerto para los fabricantes de\u00a0#dispositivosm\u00e9dicos<\/a>\u00a0puestos en servicio antes del 26\/05\/2021.
En mi opini\u00f3n, debe ser gestionada adecuadamente por los organismos notificados para priorizar la certificaci\u00f3n de nuevos\u00a0#medicaldevices<\/a>, y proporcionar respiro a aquellas empresas de reciente creaci\u00f3n que a fecha de hoy est\u00e1n a la espera de que un organismo notificado acepte su solicitud de sus productos innovadores.<\/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":"

Ha entrado en vigor el REGLAMENTO (UE) 2023\/607 prorrogando la validez de los certificados expedidos de conformidad con las Directivas 90\/385\/CEE y 93\/42\/CEE.<\/p>\n","protected":false},"author":1,"featured_media":1387,"comment_status":"closed","ping_status":"open","sticky":true,"template":"elementor_header_footer","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":[7,8],"tags":[5,6],"class_list":["post-1305","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mdd","category-md","tag-medical-devices","tag-plazos-mdd"],"yoast_head":"\nAmpliaci\u00f3n plazo validez Directiva MDD - MeDev<\/title>\n<meta name=\"description\" content=\"Ha entrado en vigor el REGLAMENTO (UE) 2023\/607 prorrogando, minimo hasta 2027, la validez de los certificados expedidos de conformidad con las Directivas 90\/385\/CEE y 93\/42\/CEE.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/medev.es\/?p=1305\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ampliaci\u00f3n plazo validez Directiva MDD - 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