{"id":33439,"date":"2024-12-18T15:10:42","date_gmt":"2024-12-18T14:10:42","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/12\/18\/rapporti-di-pms-e-psur-documenti-chiave-nella-sorveglianza-post-market\/"},"modified":"2025-08-18T15:33:39","modified_gmt":"2025-08-18T13:33:39","slug":"rapporti-di-pms-e-psur-documenti-chiave-nella-sorveglianza-post-market","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2024\/12\/18\/rapporti-di-pms-e-psur-documenti-chiave-nella-sorveglianza-post-market\/","title":{"rendered":"Informes PMS y PSUR: documentos clave en la vigilancia poscomercializaci\u00f3n"},"content":{"rendered":"<p>Los<strong> informes<\/strong> <strong>de vigilancia poscomercializaci\u00f3n (PMS Reports)<\/strong> y los <strong>informes peri\u00f3dicos actualizados en materia de seguridad (PSUR)<\/strong> desempe\u00f1an un papel central en la gesti\u00f3n de la vigilancia poscomercializaci\u00f3n (PMS) de los productos sanitarios, tal y como exige el Reglamento MDR (UE) 2017\/745. Estos documentos son esenciales para garantizar que los productos siguen cumpliendo las normas de seguridad y funcionamiento despu\u00e9s de su comercializaci\u00f3n y son partes esenciales de la documentaci\u00f3n t\u00e9cnica.<\/p>\n<p>En funci\u00f3n de la clase de riesgo del producto, el Reglamento distingue dos tipos de informes:<\/p>\n<ul>\n<li><strong>Informe PMS (art. 85):<\/strong> obligatorio para los dispositivos de clase I.<\/li>\n<li><strong>PSUR (Art. 86):<\/strong> obligatorio para los productos de las clases IIa, IIb y III.<\/li>\n<\/ul>\n<p>Ambos documentos comparten el objetivo de actualizar peri\u00f3dicamente la <strong>seguridad <\/strong>y la <strong>relaci\u00f3n beneficio-riesgo<\/strong>, pero difieren en los detalles que deben presentarse.<\/p>\n<h2><strong>Informe PMS para dispositivos de clase I<\/strong><\/h2>\n<p><a href=\"https:\/\/www.medical-device-regulation.eu\/?s=85+post+market+surveillance+report\"><strong>El art\u00edculo 85 del MDR<\/strong><\/a> indica que los fabricantes de productos de <strong>la clase I<\/strong> deben elaborar un informe de <strong>vigilancia poscomercializaci\u00f3n (PMS Report)<\/strong> en el que se resuman los resultados y las conclusiones de los an\u00e1lisis exigidos por el plan de vigilancia poscomercializaci\u00f3n (art\u00edculo 84 del MDR). El informe PMS debe incluir una justificaci\u00f3n y una descripci\u00f3n de las medidas preventivas o correctoras adoptadas, debe actualizarse cuando sea necesario y ponerse a disposici\u00f3n de la autoridad competente cuando \u00e9sta lo solicite.<\/p>\n<p>El Informe PMS incluye:<\/p>\n<ul>\n<li><strong>Recogida y an\u00e1lisis de informaci\u00f3n sobre sucesos posteriores a la comercializaci\u00f3n y<\/strong> rendimiento de los dispositivos;<\/li>\n<li><strong>Descripci\u00f3n de las medidas preventivas y correctoras adoptadas;<\/strong><\/li>\n<li><strong>A<\/strong><strong>ctualizaciones peri\u00f3dicas, <\/strong>basadas en los datos recogidos.<\/li>\n<\/ul>\n<p>El Informe PMS debe actualizarse cuando sea necesario y ponerse a disposici\u00f3n de las autoridades competentes que lo soliciten. Este documento representa una prueba tangible de la eficacia de las actividades de vigilancia poscomercializaci\u00f3n aplicadas.<\/p>\n<h2><strong>PSUR: la herramienta avanzada para dispositivos de clase media-alta<\/strong><\/h2>\n<p><a href=\"https:\/\/www.medical-device-regulation.eu\/2019\/07\/16\/mdr-article-86-periodic-safety-update-report\/\"><strong>El art\u00edculo 86 del MDR<\/strong><\/a> <strong>\u00a0<\/strong>indica que, para los productos de las clases IIa, IIb y III, los fabricantes deben elaborar un <strong>informe peri\u00f3dico actualizado en materia de seguridad<\/strong> <strong>(PSUR)<\/strong> en el que se resuman los resultados y las conclusiones del an\u00e1lisis de los datos de vigilancia recogidos con arreglo al plan de vigilancia poscomercializaci\u00f3n contemplado en el art\u00edculo 84.<\/p>\n<p>El PSUR es m\u00e1s detallado que el Informe PMS e incluye la siguiente informaci\u00f3n:<\/p>\n<ul>\n<li><strong>Evaluaci\u00f3n beneficio-riesgo <\/strong>basada en datos poscomercializaci\u00f3n;<\/li>\n<li><strong>Resultados del seguimiento cl\u00ednico poscomercializaci\u00f3n;<\/strong><\/li>\n<li><strong>Informaci\u00f3n sobre<\/strong> <strong>accidentes graves y no graves<\/strong>;<\/li>\n<li><strong>Informaci\u00f3n sobre las medidas correctivas de seguridad<\/strong> adoptadas para mitigar los riesgos emergentes, en particular las medidas correctivas de seguridad sobre el terreno (FSCA);<\/li>\n<li><strong>Respuesta del mercado<\/strong>, incluida la informaci\u00f3n facilitada por usuarios, importadores y distribuidores, comentarios y quejas;<\/li>\n<li><strong>Datos sobre dispositivos similares<\/strong> o recogidos en contextos cient\u00edficos.<\/li>\n<li><strong>Resultados de <\/strong><a href=\"https:\/\/www.thema-med.com\/2024\/11\/19\/analisi-delle-tendenze-nella-sorveglianza-post-market-pms\/\"><strong>an\u00e1lisis de tendencias<\/strong><\/a>.<\/li>\n<\/ul>\n<p>El fabricante debe actualizar el documento PSUR:<\/p>\n<ul>\n<li>Al menos <strong>una vez al a\u00f1o<\/strong> para los dispositivos de clase IIb y III.<\/li>\n<li>Cada <strong>dos a\u00f1os<\/strong> para los dispositivos de clase IIa, a menos que exista una necesidad especial.<\/li>\n<\/ul>\n<p>Los PSUR de los productos de <strong>la clase III<\/strong> o de <strong>los productos implantables<\/strong> deben ponerse a disposici\u00f3n del <strong>organismo notificado<\/strong> a trav\u00e9s de la base de datos <strong>EUDAMED <\/strong>para que puedan ser evaluados adecuadamente. \u00a0Hasta que EUDAMED est\u00e9 plenamente operativo, los PSUR se compartir\u00e1n a trav\u00e9s de modos alternativos.<\/p>\n<p>Los PSUR de <strong>los productos no implantables de las clases IIa y IIb<\/strong> deben ponerse a disposici\u00f3n del organismo notificado durante las actividades de vigilancia o previa solicitud.<\/p>\n<p><strong>Directrices <\/strong><\/p>\n<p>Adem\u00e1s del MDR (UE) 2017\/745, los fabricantes de productos sanitarios pueden consultar:<\/p>\n<ul>\n<li><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-01\/mdcg_2022-21_en.pdf\"><strong>MDCG 2022 &#8211; 21<\/strong><\/a> directriz que especifica la informaci\u00f3n que debe presentarse en un PSUR.<\/li>\n<li><strong>MDCG 2023-3<\/strong> aclaraci\u00f3n de conceptos clave relacionados con la vigilancia del mercado;<\/li>\n<\/ul>\n<h2><strong>Valor estrat\u00e9gico del Informe PMS y PSUR<\/strong><\/h2>\n<p>Ambos documentos no son simples obligaciones reglamentarias, sino que representan herramientas estrat\u00e9gicas para la organizaci\u00f3n. Sirven para <strong>mejorar la seguridad y eficacia de los dispositivos<\/strong>, proporcionando una imagen clara de los problemas y las medidas correctoras. Demuestran <strong>el cumplimiento durante las auditor\u00edas e inspecciones<\/strong>. Adem\u00e1s, apoyan las decisiones basadas en datos reales para <strong>mejorar las caracter\u00edsticas y el etiquetado de los productos<\/strong>.<\/p>\n<p>El informe PMS y el PSUR son elementos indispensables de una gesti\u00f3n eficaz de la vigilancia poscomercializaci\u00f3n.<\/p>\n<p><strong>THEMA<\/strong> puede apoyarle en la gesti\u00f3n de la documentaci\u00f3n poscomercializaci\u00f3n y en la redacci\u00f3n de Informes PMS y PSUR a trav\u00e9s de sus servicios de <strong>consultor\u00eda estrat\u00e9gica-regulatoria<\/strong>. Adem\u00e1s, Thema proporciona sus propios modelos validados y utilizados por cientos de clientes a lo largo de muchos a\u00f1os de experiencia: <a href=\"https:\/\/www.thema-med.com\/download-template\/modulo-psur-periodic-safety-update-report\/\"><strong>MODELO PSUR<\/strong><\/a> e\u00a0 <a href=\"https:\/\/www.thema-med.com\/download-template\/modulo-rapporto-sorveglianza-post-market-pmsr\/\"><strong>MODELO Informe PMS<\/strong><\/a>. Los modelos le permitir\u00e1n preparar usted mismo la documentaci\u00f3n necesaria, de acuerdo con los requisitos del Reglamento MDR.<\/p>\n<p>&nbsp;<\/p>\n<p><em>18\/12\/2024<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Los informes de vigilancia poscomercializaci\u00f3n (PMS Reports) y los informes peri\u00f3dicos actualizados en materia de seguridad (PSUR) desempe\u00f1an un papel central  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33478,"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-33439","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 - 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