{"id":29754,"date":"2023-07-27T09:03:22","date_gmt":"2023-07-27T07:03:22","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=29754"},"modified":"2023-07-28T12:18:12","modified_gmt":"2023-07-28T10:18:12","slug":"el-plan-de-vigilancia-post-mercado-pmsp","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2023\/07\/27\/el-plan-de-vigilancia-post-mercado-pmsp\/","title":{"rendered":"El Plan de Vigilancia Post-Mercado (PMSP)"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p style=\"text-align: right;\">27 julio 2023<\/p>\n<p>El MDR (EU) 2017\/745 describe y desarrolla la estructura y el contenido m\u00ednimo del <strong>Plan de Vigilancia Post-Mercado (PMSP) <\/strong>que anteriormente solo se mencionaba en el MDD 93\/42\/EEC modificado.<\/p>\n<p>El MDR (UE) 2017\/745 en su <strong>Anexo III<\/strong> exige a los Fabricantes disponer de un <strong>procedimiento sistem\u00e1tico de Vigilancia Poscomercializaci\u00f3n (SPM)<\/strong>, incluyendo un <strong>Plan<\/strong>, que se aplicar\u00e1 a la organizaci\u00f3n y relativo a cada producto y\/o familia de productos.<\/p>\n<p>En concreto, el fabricante debe implantar, para cada producto sanitario, un sistema de vigilancia posterior a la comercializaci\u00f3n que <strong>recoja, registre y analice<\/strong> datos sobre la calidad, el funcionamiento y la seguridad del producto.<\/p>\n<p>Los datos recogidos se utilizar\u00e1n para:<\/p>\n<ul>\n<li>actualizar la <strong>evaluaci\u00f3n de riesgos<\/strong> y <strong>beneficios<\/strong>;<\/li>\n<li>actualizar la informaci\u00f3n sobre el <strong>dise\u00f1o <\/strong>y la <strong>fabricaci\u00f3n<\/strong>, <strong>las instrucciones de uso<\/strong> y el <strong>etiquetado<\/strong>;<\/li>\n<li>actualizar la <strong>evaluaci\u00f3n cl\u00ednica<\/strong>;<\/li>\n<li>actualizar el <strong>resumen<\/strong> de seguridad y rendimiento cl\u00ednico;<\/li>\n<li>identificar las necesidades de <strong>acciones preventivas<\/strong> y <strong>correctivas<\/strong>;<\/li>\n<li>contribuir a la <strong>vigilancia posterior a la comercializaci\u00f3n<\/strong> de otros productos;<\/li>\n<li>identificar y notificar <strong>tendencias<\/strong>.<\/li>\n<\/ul>\n<p>El sistema de vigilancia poscomercializaci\u00f3n debe formar parte del <strong>Sistema de Gesti\u00f3n de la Calidad<\/strong> y actualizarse continuamente.<\/p>\n<p>El art\u00edculo 84 del MDR establece que el sistema de vigilancia poscomercializaci\u00f3n debe basarse en un <strong>plan de vigilancia poscomercializaci\u00f3n (PSCP),<\/strong> cuyos requisitos se establecen en el anexo III y que debe formar parte de la documentaci\u00f3n t\u00e9cnica del anexo II.<\/p>\n<p>El punto I del Anexo III, precisamente, define que los <strong>contenidos esenciales<\/strong> del plan PMS son:<\/p>\n<ul>\n<li>datos sobre <strong>incidentes graves<\/strong>, incluida la informaci\u00f3n de los PSUR y las acciones correctivas de seguridad sobre el terreno;<\/li>\n<li>informaci\u00f3n sobre <strong>incidentes no graves<\/strong> y datos sobre posibles efectos secundarios<\/li>\n<li>informes de <strong>tendencias<\/strong>;<\/li>\n<li><strong>reclamaciones<\/strong> facilitadas por usuarios, distribuidores e importadores;<\/li>\n<li>datos sobre productos sanitarios <strong>similares<\/strong>.<\/li>\n<\/ul>\n<ol>\n<li><strong>PLAN DE SEGUIMIENTO CL\u00cdNICO POSTCOMERCIALIZACI\u00d3N (PMCFP)<\/strong><\/li>\n<\/ol>\n<p>El proceso de vigilancia poscomercializaci\u00f3n debe incluir, entre otras cosas, un <strong>plan poscomercializaci\u00f3n<\/strong><\/p>\n<p>El proceso de vigilancia posterior a la comercializaci\u00f3n (PMS) debe incluir, entre otras cosas, di y un <strong>plan de seguimiento cl\u00ednico posterior a la comercializaci\u00f3n (PMCFP)<\/strong> o una raz\u00f3n por la que el proceso no es aplicable. El proceso de evaluaci\u00f3n cl\u00ednica que consiste en la generaci\u00f3n, recopilaci\u00f3n, an\u00e1lisis y evaluaci\u00f3n continuos de datos cl\u00ednicos debe verificar la <strong>seguridad<\/strong>, el <strong>rendimiento<\/strong> y el <strong>beneficio cl\u00ednico<\/strong> de un Producto Sanitario, est\u00e1 directamente vinculado al sistema de vigilancia posterior a la comercializaci\u00f3n y debe incluir el proceso de Seguimiento Cl\u00ednico Posterior a la Comercializaci\u00f3n (SSPC).<\/p>\n<p>El PMCF hace referencia a un proceso continuo que actualiza la evaluaci\u00f3n cl\u00ednica y se aborda en el plan de vigilancia poscomercializaci\u00f3n del fabricante. Al realizar el seguimiento poscomercializaci\u00f3n, el fabricante recopila y eval\u00faa <strong>de forma proactiva<\/strong> datos cl\u00ednicos relacionados con el uso en humanos de un <strong>producto que lleva el marcado CE<\/strong> y se comercializa o se pone en servicio dentro de los l\u00edmites del uso previsto especificado en el procedimiento de evaluaci\u00f3n de la conformidad pertinente, a fin de confirmar la seguridad y el funcionamiento durante toda la vida \u00fatil prevista del producto, garantizar la aceptabilidad continua de los riesgos identificados y detectar riesgos emergentes basados en pruebas objetivas (parte B del anexo XIV).<\/p>\n<p>Para la aplicaci\u00f3n del proceso PMCF, el mismo anexo exige que el fabricante establezca un m\u00e9todo documentado en un <strong>plan de seguimiento cl\u00ednico poscomercializaci\u00f3n<\/strong> (PMCFP) estableciendo sus requisitos m\u00ednimos de contenido.<\/p>\n<p>&gt;&gt;&gt; Tiene dificultades para instalar la PMSP?<\/p>\n<p>Para demostrar la aplicaci\u00f3n del proceso de vigilancia poscomercializaci\u00f3n, los organismos reguladores exigen la presentaci\u00f3n de los planes pertinentes y <strong>no es f\u00e1cil<\/strong> definir una estructura y un contenido de documento adecuados.<\/p>\n<p>THEMA puede facilitar y agilizar la preparaci\u00f3n del PMSP proporcion\u00e1ndole una <strong>plantilla ya \u00ablista para usar\u00bb<\/strong> y validada por una larga y s\u00f3lida experiencia en el sector y en la aplicaci\u00f3n del MDR (UE) 2017\/745.<\/p>\n<p>\u00bfQuieres saber c\u00f3mo conseguir tu propia plantilla? Haz clic <strong><a href=\"https:\/\/www.thema-med.com\/es\/descargar-template\/modulo-plan-de-seguimiento-poscomercializacion-pmsr\/\">aqu\u00ed<\/a><\/strong><\/p>\n<p><strong>Let\u2019s take care beyond the boundaries.<\/strong><\/p><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":29747,"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":[680],"tags":[],"class_list":["post-29754","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>El Plan de Vigilancia Post-Mercado (PMSP) - 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