{"id":1145,"date":"2025-06-20T19:33:00","date_gmt":"2025-06-20T18:33:00","guid":{"rendered":"https:\/\/www.md-amconsulting.es\/?p=1145"},"modified":"2025-06-20T19:34:10","modified_gmt":"2025-06-20T18:34:10","slug":"dispositivos-heredados-mdr-mdcg-2021-25","status":"publish","type":"post","link":"https:\/\/www.md-amconsulting.es\/index.php\/2025\/06\/20\/dispositivos-heredados-mdr-mdcg-2021-25\/","title":{"rendered":"Lo que exige el MDR para dispositivos heredados seg\u00fan la MDCG 2021-25"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Dispositivos heredados MDR: aplicaci\u00f3n y obligaciones<\/h2>\n\n\n\n<p>La <strong>gu\u00eda <\/strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en\"><strong>MDCG\u202f2021\u201125<\/strong> <\/a>aclara c\u00f3mo aplicar el MDR (Reglamento\u202fUE\u202f745\/2017) a los <strong>dispositivos heredados MDR<\/strong> durante las fases transitorias del art\u00edculo\u202f120. Tambi\u00e9n orienta a los organismos notificados y operadores econ\u00f3micos sobre sus responsabilidades.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u00bfQu\u00e9 establece el art\u00edculo\u202f120 del MDR?<\/h4>\n\n\n\n<p>Los productos con certificado CE bajo las directivas MDD o AIMDD podr\u00e1n seguir comercializ\u00e1ndose hasta su caducidad, o hasta el 26 de mayo de 2024, siempre y cuando se cumplan <strong>dos condiciones principales<\/strong>:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>No se modifique el dise\u00f1o ni el uso previsto del producto.<\/li>\n\n\n\n<li>Se apliquen los requisitos del MDR: vigilancia poscomercializaci\u00f3n, control de mercado, registros de agentes y de productos \u2013 vigentes desde mayo de 2021.<\/li>\n<\/ol>\n\n\n\n<h4 class=\"wp-block-heading\">\u00bfQu\u00e9 son los \u201cdispositivos heredados MDR\u201d?<\/h4>\n\n\n\n<p>Seg\u00fan la gu\u00eda:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Se consideran <strong>dispositivos heredados MDR<\/strong> aquellos certificados conforme a directiva y comercializados tras el 26 de mayo de 2021.<\/li>\n\n\n\n<li>Para los <strong>dispositivos de clase I auto-certificados<\/strong>, la declaraci\u00f3n de conformidad deb\u00eda firmarse antes del 26 de mayo de 2021.<\/li>\n<\/ul>\n\n\n\n<p>Tambi\u00e9n se definen:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Dispositivos antiguos<\/strong>: certificados y comercializados antes del 26 de mayo de 2021.<\/li>\n\n\n\n<li><strong>Dispositivos MDR<\/strong>: introducidos conforme al nuevo reglamento.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Requisitos para dispositivos heredados MDR<\/h4>\n\n\n\n<p>Seg\u00fan MDCG 2021-25:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Los fabricantes deben cumplir el cap\u00edtulo\u202fVII del MDR (poscomercializaci\u00f3n, vigilancia, control de mercado).<\/li>\n\n\n\n<li>Los organismos notificados deben realizar seguimiento activo del cumplimiento.<\/li>\n<\/ul>\n\n\n\n<p>Adem\u00e1s:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Clase\u202fI: informes de seguimiento poscomercializaci\u00f3n (art.\u202f85).<\/li>\n\n\n\n<li>Clases\u202fIIa, IIb y III: informes peri\u00f3dicos de seguridad (art.\u202f86).<\/li>\n\n\n\n<li>Dispositivos implantables activos AIMDD se consideran clase III durante la transici\u00f3n.<\/li>\n\n\n\n<li>Si un kit combina \u201cproductos heredados MDR\u201d con productos MDR, aplica el art.\u202f22; si no, no aplica.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Importadores y distribuidores<\/h4>\n\n\n\n<p>Importadores y distribuidores de <strong>dispositivos heredados MDR<\/strong> tambi\u00e9n son responsables seg\u00fan el art.\u202f120(3): deben asegurarse del cumplimiento antes de introducir o comercializar los productos en la UE.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">\u00bfY los dispositivos antiguos?<\/h4>\n\n\n\n<p>Para estos, la MDCG aclara que solo se aplican los art\u00edculos 93 a 100 del MDR. Esto permite a las autoridades verificar que fueron conformes al momento de su comercializaci\u00f3n y tomar medidas si detectan riesgos.<\/p>\n\n\n\n<p>La <strong>MDCG\u202f2021\u201125<\/strong> brinda claridad sobre los <strong>dispositivos heredados MDR<\/strong>, definiendo obligaciones espec\u00edficas para fabricantes, organismos notificados, importadores y distribuidores. El cumplimiento del MDR, incluso en periodo transitorio, es esencial para vender estos productos legalmente.<\/p>\n\n\n\n<p>Si quieres que profundicemos en un tema concreto o necesitas ayuda para implementar estas medidas, escr\u00edbenos a: <strong><a>info@md-amconsulting.es<\/a><\/strong> o rellena el formulario de <a href=\"https:\/\/www.md-amconsulting.es\/index.php\/pagina-de-contacto\/\">contacto. <\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dispositivos heredados MDR: aplicaci\u00f3n y obligaciones La gu\u00eda MDCG\u202f2021\u201125 aclara c\u00f3mo aplicar el MDR (Reglamento\u202fUE\u202f745\/2017) a los dispositivos heredados MDR durante las fases transitorias del art\u00edculo\u202f120. Tambi\u00e9n orienta a los organismos notificados y operadores econ\u00f3micos sobre sus responsabilidades. \u00bfQu\u00e9 establece el art\u00edculo\u202f120 del MDR? Los productos con certificado CE bajo las directivas MDD o AIMDD [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1146,"comment_status":"open","ping_status":"open","sticky":false,"template":"page-blog","format":"standard","meta":{"saved_in_kubio":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[50],"tags":[26,12,68,18,59],"class_list":["post-1145","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-auditoria","tag-consultoria","tag-evaluacion-clinica","tag-marcado-ce","tag-mdr"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Dispositivos heredados MDR: aplicaci\u00f3n y obligaciones - AMConsulting Medical Devices<\/title>\n<meta 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