{"id":3234,"date":"2025-01-21T12:56:01","date_gmt":"2025-01-21T12:56:01","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3234"},"modified":"2025-01-21T12:56:01","modified_gmt":"2025-01-21T12:56:01","slug":"mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/","title":{"rendered":"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background 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:1248px;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:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><b>The Medicines and Healthcare products Regulatory Agency (MHRA)<\/b> has released official guidance to help medical device manufacturers prepare for the updated <b>Post-Market Surveillance (PMS)<\/b> requirements, effective <b>June 16, 2025<\/b>.<\/p>\n<p><b>What is PMS?<br \/>\n<\/b><br \/>\nPMS is a mandatory system designed to monitor devices on the market, identify risks, and ensure safe usage throughout their lifecycle.<\/p>\n<p><b>Key Updates from MHRA Guidance<br \/>\n<\/b><br \/>\n<b>1. Enhanced data collection:<\/b> Continuous monitoring of quality and safety.<br \/>\n<b>2. Shorter reporting timelines:<\/b><br \/>\n&#8211; <b>2 working days<\/b> for public health threats.<br \/>\n&#8211; <b>10 working days<\/b> for deaths or serious injuries.<br \/>\n&#8211; <b>15 working days<\/b> for other serious incidents.<br \/>\n<b>3. Mandatory periodic summaries:<\/b> Early identification of safety issues.<br \/>\n<b>4. Risk mitigation and communication: <\/b>Clear guidance for managing risks and protecting users.<\/p>\n<p><b>MHRA recommends:<\/b><br \/>\n&#8211; Applying the guidance immediately.<br \/>\n&#8211; Collaborating with trade associations for further support and feedback.<\/p>\n<p><a href=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/01\/The-Medical-Devices-Post-market-Surveillance-Requirements-Amendment-Great-Britain-Regulations-2024.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><u><b>Download the guide here<\/b><\/u><\/a><\/p>\n<p><b>Need Support?<\/b><\/p>\n<p>Our team is here to assist you in meeting the new PMS requirements. <b style=\"color: var(--awb-text-color); font-family: var(--awb-text-font-family); font-size: var(--awb-font-size); font-style: var(--awb-text-font-style); letter-spacing: var(--awb-letter-spacing); text-align: var(--awb-content-alignment); text-transform: var(--awb-text-transform); background-color: var(--awb-bg-color-hover);\">Contact us for personalized advice.<\/b><\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:10px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us <\/span><\/a><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    data-payload='{&quot;align&quot;:&quot;center&quot;,&quot;id&quot;:&quot;3234&quot;,&quot;slug&quot;:&quot;default&quot;,&quot;valign&quot;:&quot;bottom&quot;,&quot;ignore&quot;:&quot;&quot;,&quot;reference&quot;:&quot;auto&quot;,&quot;class&quot;:&quot;&quot;,&quot;count&quot;:&quot;0&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;0&quot;,&quot;starsonly&quot;:&quot;&quot;,&quot;best&quot;:&quot;5&quot;,&quot;gap&quot;:&quot;5&quot;,&quot;greet&quot;:&quot;Rate this&quot;,&quot;legend&quot;:&quot;0\\\/5 - (0 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements&quot;,&quot;width&quot;:&quot;0&quot;,&quot;_legend&quot;:&quot;{score}\\\/{best} - ({count} {votes})&quot;,&quot;font_factor&quot;:&quot;1.25&quot;}'>\n            \n<div class=\"kksr-stars\">\n    \n<div class=\"kksr-stars-inactive\">\n            <div class=\"kksr-star\" data-star=\"1\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"2\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"3\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"4\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" data-star=\"5\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n    \n<div class=\"kksr-stars-active\" style=\"width: 0px;\">\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n            <div class=\"kksr-star\" style=\"padding-right: 5px\">\n            \n\n<div class=\"kksr-icon\" style=\"width: 24px; height: 24px;\"><\/div>\n        <\/div>\n    <\/div>\n<\/div>\n                \n\n<div class=\"kksr-legend\" style=\"font-size: 19.2px;\">\n            <span class=\"kksr-muted\">Rate this<\/span>\n    <\/div>\n    <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1,31],"tags":[],"class_list":["post-3234","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","category-sin-categorizar-es","post_format-post-format-gallery"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.3.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements | CMC Medical Devices<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements | CMC Medical Devices\" \/>\n<meta property=\"og:url\" content=\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/\" \/>\n<meta property=\"og:site_name\" content=\"CMC Medical Devices\" \/>\n<meta property=\"article:published_time\" content=\"2025-01-21T12:56:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-CMC.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"675\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/\"},\"author\":{\"name\":\"Admin\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf\"},\"headline\":\"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements\",\"datePublished\":\"2025-01-21T12:56:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/\"},\"wordCount\":748,\"publisher\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#organization\"},\"articleSection\":[\"Sin categorizar\",\"Sin categorizar\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/\",\"url\":\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/\",\"name\":\"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements | CMC Medical Devices\",\"isPartOf\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#website\"},\"datePublished\":\"2025-01-21T12:56:01+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\/\/cmcmedicaldevices.com\/es\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#website\",\"url\":\"https:\/\/cmcmedicaldevices.com\/\",\"name\":\"CMC Medical Devices\",\"description\":\"In Country Representation and Global Consulting for medical devices\",\"publisher\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#organization\"},\"alternateName\":\"CMC\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/cmcmedicaldevices.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#organization\",\"name\":\"CMC Medical Devices\",\"alternateName\":\"CMC CONSULTING GROUP\",\"url\":\"https:\/\/cmcmedicaldevices.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-cuadrado-CMC.webp\",\"contentUrl\":\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-cuadrado-CMC.webp\",\"width\":675,\"height\":675,\"caption\":\"CMC Medical Devices\"},\"image\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf\",\"name\":\"Admin\",\"url\":\"https:\/\/cmcmedicaldevices.com\/es\/author\/admin-2\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements | CMC Medical Devices","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/","og_locale":"es_ES","og_type":"article","og_title":"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements | CMC Medical Devices","og_url":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/","og_site_name":"CMC Medical Devices","article_published_time":"2025-01-21T12:56:01+00:00","og_image":[{"width":1200,"height":675,"url":"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-CMC.webp","type":"image\/webp"}],"author":"Admin","twitter_card":"summary_large_image","twitter_misc":{"Escrito por":"Admin","Tiempo de lectura":"1 minuto"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/#article","isPartOf":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/"},"author":{"name":"Admin","@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf"},"headline":"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements","datePublished":"2025-01-21T12:56:01+00:00","mainEntityOfPage":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/"},"wordCount":748,"publisher":{"@id":"https:\/\/cmcmedicaldevices.com\/#organization"},"articleSection":["Sin categorizar","Sin categorizar"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/","url":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/","name":"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements | CMC Medical Devices","isPartOf":{"@id":"https:\/\/cmcmedicaldevices.com\/#website"},"datePublished":"2025-01-21T12:56:01+00:00","breadcrumb":{"@id":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/cmcmedicaldevices.com\/es\/mhra-updates-post-market-surveillance-how-to-adapt-your-medical-devices-to-new-requirements\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/cmcmedicaldevices.com\/es\/"},{"@type":"ListItem","position":2,"name":"MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements"}]},{"@type":"WebSite","@id":"https:\/\/cmcmedicaldevices.com\/#website","url":"https:\/\/cmcmedicaldevices.com\/","name":"CMC Medical Devices","description":"In Country Representation and Global Consulting for medical devices","publisher":{"@id":"https:\/\/cmcmedicaldevices.com\/#organization"},"alternateName":"CMC","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/cmcmedicaldevices.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/cmcmedicaldevices.com\/#organization","name":"CMC Medical Devices","alternateName":"CMC CONSULTING GROUP","url":"https:\/\/cmcmedicaldevices.com\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/logo\/image\/","url":"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-cuadrado-CMC.webp","contentUrl":"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-cuadrado-CMC.webp","width":675,"height":675,"caption":"CMC Medical Devices"},"image":{"@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf","name":"Admin","url":"https:\/\/cmcmedicaldevices.com\/es\/author\/admin-2\/"}]}},"_links":{"self":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts\/3234","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/comments?post=3234"}],"version-history":[{"count":1,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts\/3234\/revisions"}],"predecessor-version":[{"id":3235,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/posts\/3234\/revisions\/3235"}],"wp:attachment":[{"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/media?parent=3234"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/categories?post=3234"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cmcmedicaldevices.com\/es\/wp-json\/wp\/v2\/tags?post=3234"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}