{"id":3773,"date":"2025-06-13T11:40:37","date_gmt":"2025-06-13T11:40:37","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3773"},"modified":"2025-07-18T09:52:17","modified_gmt":"2025-07-18T09:52:17","slug":"what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/","title":{"rendered":"What are the new Post-Market Surveillance requirements in the uk from june 2025?"},"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>Starting 16 June 2025<\/b>, new post-market surveillance (PMS) obligations will apply to all medical devices placed on the market in Great Britain. These changes affect <b>in vitro diagnostic (IVD) devices<\/b>, implantables, and all classes of general medical devices.<\/p>\n<p>Manufacturers, authorised representatives, and other economic operators must be ready to meet these new requirements.<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/#What_are_the_main_changes_introduced_by_the_new_uk_PMS_rules\" >What are the main changes introduced by the new uk PMS rules?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/#What_is_a_PMS_plan_and_who_needs_it\" >What is a PMS plan and who needs it?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/#How_should_PMS_reports_be_handled\" >How should PMS reports be handled?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/#What_are_the_new_incident_reporting_rules\" >What are the new incident reporting rules?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/#How_fast_must_you_respond_to_MHRA_requests\" >How fast must you respond to MHRA requests?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/#How_can_you_prepare_before_16_june_2025\" >How can you prepare before 16 june 2025?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/#Summary_of_key_obligations\" >Summary of key obligations<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/cmcmedicaldevices.com\/es\/what-are-the-new-post-market-surveillance-requirements-in-the-uk-from-june-2025\/#Need_help_navigating_the_new_UK_PMS_obligations\" >Need help navigating the new UK PMS obligations?<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"What_are_the_main_changes_introduced_by_the_new_uk_PMS_rules\"><\/span>What are the main changes introduced by the new uk PMS rules?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>The Medical Devices (Post-Market Surveillance Requirements)<\/b> (Amendment) Regulations 2024 introduce a new <b>Part 4A into the UK MDR 2002<\/b>.<br \/>\nHere are the key updates:<\/p>\n<ul>\n<li><strong>Mandatory PMS requirements<\/strong> for all devices placed on the market in Great Britain, including IVDs and implantables<\/li>\n<li><strong>Clear terminology<\/strong>: new definitions such as \u201cdevice lifetime\u201d and \u201cPMS period,\u201d with the recommendation to continue monitoring beyond the validated lifetime<\/li>\n<li><strong>Risk-based PMS plans<\/strong>: manufacturers must document objectives, data sources (including public and patient feedback), and update frequency<\/li>\n<li><strong>Periodic reports<\/strong>:\n<ul>\n<li><em>low-risk devices<\/em>: PMSR at least every 3 years<\/li>\n<li><em>higher-risk devices (class IIb, III, and IVD class C\/D)<\/em>: annual PSUR, submitted to the UK Approved Body (UKAB)<\/li>\n<\/ul>\n<\/li>\n<li><strong>Incident reporting<\/strong>:\n<ul>\n<li>shortened deadline of 15 days (previously 30) for serious incidents or risks<\/li>\n<li>mandatory inclusion of the UDI<\/li>\n<li>detailed tracking of investigations and corrective actions<\/li>\n<\/ul>\n<\/li>\n<li><strong>Access to PMS documents<\/strong>: the MHRA may request PMSR or PSUR at any time, and manufacturers must respond within 3 working days<\/li>\n<li><strong>Updated templates available<\/strong>: new PMS and incident reporting forms must be used starting 16 May 2025. These templates reflect the updated requirements and ensure that submitted documentation meets MHRA standards.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_PMS_plan_and_who_needs_it\"><\/span>What is a PMS plan and who needs it?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Every manufacturer placing a device on the GB market from 16 June onwards must prepare a written PMS plan appropriate to the device\u2019s risk class<\/b>. The plan must be regularly reviewed and available to the MHRA if requested.<\/p>\n<p>The PMS plan helps demonstrate proactive monitoring of device safety and performance throughout its lifecycle.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_should_PMS_reports_be_handled\"><\/span>How should PMS reports be handled?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>PMS reports are essential for documenting the effectiveness of your surveillance strategy. They must identify trends, assess risks, and include actions taken to protect patients and users.<\/p>\n<ul>\n<li><b>PMSR (Post-Market Surveillance Report) <\/b>is required for low-risk devices<\/li>\n<li><b>PSUR (Periodic Safety Update Report)<\/b> is required for medium to high-risk devices and must be submitted to the UKAB<\/li>\n<\/ul>\n<p>These reports are key to maintaining access to the GB market.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_are_the_new_incident_reporting_rules\"><\/span>What are the new incident reporting rules?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Reporting timelines are now stricter. Serious incidents or potential risks must be reported to the MHRA within <strong>15 calendar days<\/strong>.<\/p>\n<p>The report must include:<\/p>\n<ul>\n<li>The UDI of the affected device<\/li>\n<li>The nature of the incident or risk<\/li>\n<li>Investigation results and any actions taken<\/li>\n<\/ul>\n<p>Updated reporting forms must be used from 16 May 2025.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_fast_must_you_respond_to_MHRA_requests\"><\/span>How fast must you respond to MHRA requests?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>If the MHRA asks for a PMSR or PSUR, the manufacturer must provide it <strong>within 3 working days<\/strong>.<\/p>\n<p>Being unprepared may lead to enforcement actions or delays in market access.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_can_you_prepare_before_16_june_2025\"><\/span>How can you prepare before 16 june 2025?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>Here are five steps to help you comply:<\/b><\/p>\n<ul>\n<li>Review and update your PMS procedures<\/li>\n<li>Create risk-based PMS plans for each device<\/li>\n<li>Train your teams on new reporting rules<\/li>\n<li>Ensure alignment with your UKRP and UKAB<\/li>\n<li>Test your internal systems to deliver documentation quickly<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Summary_of_key_obligations\"><\/span>Summary of key obligations<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>New PMS rules apply in GB from 16 June 2025<\/li>\n<li>PMS plans are mandatory and must be adapted to risk<\/li>\n<li>PMSR and PSUR reporting is required at defined intervals<\/li>\n<li>Serious incidents must be reported within 15 days<\/li>\n<li>PMS documents must be available to the MHRA within 3 working days<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Need_help_navigating_the_new_UK_PMS_obligations\"><\/span>Need help navigating the new UK PMS obligations?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><b>We support manufacturers with tailored compliance strategies. <span style=\"background-color: rgba(0, 0, 0, 0);\">Contact us to discuss how we can help you stay compliant.<\/span><\/b><\/p>\n<p><strong>Source:<\/strong> For full guidance on the updated post-market surveillance requirements in the UK, visit the official MHRA page: <u><a href=\"https:\/\/www.gov.uk\/government\/publications\/medical-devices-post-market-surveillance-requirements\/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation?utm_source=chatgpt.com\" target=\"_blank\" rel=\"noopener noreferrer\"><b>MHRA \u2013 Guidance on implementation of the 2024 PMS amendment.<\/b><\/a><\/u><\/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:20px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/contact\/\"><span class=\"fusion-button-text\">Contact us for more information<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1640\" height=\"924\" alt=\"UK PMS\" title=\"UK PMS\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/UK-PMS-1.jpg\" class=\"img-responsive wp-image-3767\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/UK-PMS-1-200x113.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/UK-PMS-1-400x225.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/UK-PMS-1-600x338.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/UK-PMS-1-800x451.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/UK-PMS-1-1200x676.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/06\/UK-PMS-1.jpg 1640w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/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;3773&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;5&quot;,&quot;legendonly&quot;:&quot;&quot;,&quot;readonly&quot;:&quot;&quot;,&quot;score&quot;:&quot;5&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;5\\\/5 - (5 votos)&quot;,&quot;size&quot;:&quot;24&quot;,&quot;title&quot;:&quot;What are the new Post-Market Surveillance requirements in the uk from june 2025?&quot;,&quot;width&quot;:&quot;142.5&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: 142.5px;\">\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            5\/5 - (5 votos)    <\/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],"tags":[],"class_list":["post-3773","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","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>UK post-market surveillance: new requirements from June 2025<\/title>\n<meta name=\"description\" content=\"New UK post-market surveillance rules apply from 16 June 2025. 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