{"id":34150,"date":"2025-06-10T15:50:19","date_gmt":"2025-06-10T13:50:19","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34150"},"modified":"2025-06-16T16:49:17","modified_gmt":"2025-06-16T14:49:17","slug":"post-market-surveillance-of-medical-devices-in-great-britain-whats-changing","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2025\/06\/10\/post-market-surveillance-of-medical-devices-in-great-britain-whats-changing\/","title":{"rendered":"Post-Market Surveillance of Medical Devices in Great Britain: What&#8217;s Changing?"},"content":{"rendered":"<p><strong>Post-market<\/strong> <strong>surveillance (PMS) of<\/strong> <strong>medical devices in Great Britain <\/strong>plays a key role in ensuring user safety and compliance.<\/p>\n<p>With the entry into force on <strong>June 16, 2025, <\/strong>of the <a href=\"https:\/\/www.legislation.gov.uk\/uksi\/2024\/1368\/made\/data.html\"><strong><em>Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024<\/em><\/strong><\/a><strong><em>,<\/em><\/strong> medical device manufacturers in Great Britain face new and more stringent requirements.<\/p>\n<p>The amendment represents the first concrete step in the post-Brexit reform for medical devices in Great Britain and paves the way for further regulatory updates planned for 2025 and 2026. Understanding and adjusting to the new<strong> PMS <\/strong>rules<strong> for medical devices in Great Britain <\/strong>is not only an obligation, but also a strategic opportunity to preside over a competitive market.<\/p>\n<h2><strong>The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: Goals<\/strong><\/h2>\n<p>The Amendment <em>The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024<\/em> introduces a <strong>new Part 4A <\/strong>to the existing UK Medical Devices Regulations (MDR) 2002, focusing on Post-Market Surveillance requirements for Medical Devices in Great Britain (England, Scotland and Wales).<\/p>\n<p>The new provisions apply to <strong>all medical devices placed on the market in<\/strong> Great Britain, including <strong>in vitro diagnostic medical devices (IVDs)<\/strong> and <strong>active implantable medical devices<\/strong>, irrespective of PMS activities already carried out by manufacturers in other countries, such as the European Union.<\/p>\n<p>The measures introduced are aimed at improving the <strong>traceability of incidents<\/strong> and <strong>trends<\/strong>, enabling the <strong>Medicines and Healthcare products Regulatory Agency (MHRA<\/strong>) to intervene promptly when necessary. This contributes to <strong>more effective risk management<\/strong>, facilitates the <strong>early identification <\/strong>of security problems and their rapid mitigation, resulting in a <strong>reduction of potential damage<\/strong>.<\/p>\n<h2><strong>Main novelties for Post-Market Surveillance in Great Britain<\/strong><\/h2>\n<p>The new provisions present significant novelties for the Post-Market Surveillance of Medical Devices in Great Britain, particularly regarding the timing of reporting and incident management.<\/p>\n<h2>1. Supervision: stricter reporting deadlines<\/h2>\n<ul>\n<li><strong>Serious threat to public health<\/strong>: report to the MHRA within 2 working days of knowledge of the fact.<\/li>\n<li><strong>Death or serious and unforeseen worsening of the state of health<\/strong>: report to the MHRA within 10 working days of knowledge of the fact.<\/li>\n<li><strong>Expected serious worsening of the health condition:<\/strong> reporting within 15 working days of knowledge, a considerable reduction from the previous 30 days.<\/li>\n<li><strong>Manufacturers are responsible<\/strong> for investigating accidents and must provide any information requested by the MHRA within<strong> three working days<\/strong>.<\/li>\n<\/ul>\n<p>In addition, foreign manufacturers not established in the UK are obliged to inform their <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/servizio-di-uk-responsible-person\/\"><strong>UK Responsible Person,<\/strong><\/a> i.e. the figure responsible for regulatory compliance for medical devices placed on the UK market.<\/p>\n<h2>2. Corrective Actions (FSCA) and Safety Notices (FSN)<\/h2>\n<ul>\n<li><strong>Field Safety Corrective Actions (FSCAs)<\/strong> must be communicated to the MHRA before or simultaneously with their implementation.<\/li>\n<li>If the MHRA requests updates, the manufacturer is obliged to provide the information <strong>within three working days.<\/strong><\/li>\n<li>All FSCAs must be <strong>communicated to affected customers<\/strong> using a <strong>Field Safety Notice (FSN<\/strong>).<\/li>\n<li><strong>Safety Notices<\/strong> must be easy to find, clear, concise, without commercial messages, must include UDI, MHRA registration number (if available), description of the problem, required action and must <strong>effectively reach all end users<\/strong>. It is good practice to publish them on your website to ensure traceability and monitor the effectiveness of communication.<\/li>\n<li>If a Safety Corrective Action (FSCA) is taken <strong>outside Great Britain<\/strong> &#8211; excluding Northern Ireland &#8211; for devices similar to those also distributed in Great Britain, the MHRA must still be informed within <strong>3 working days<\/strong>.<\/li>\n<\/ul>\n<p>The requirements reflect greater transparency and traceability, raising the standards of manufacturer responsibility.<\/p>\n<h2>3. PMS and PSUR documentation: a proactive and verifiable system<\/h2>\n<p>The <em>Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024<\/em> introduce the requirement for a documented and risk-proportionate <strong>Post-Market Surveillance Plan (PMS Plan) <\/strong>for <strong>all devices<\/strong>, a requirement that was not always equally provided for and structured before.<\/p>\n<ul>\n<li>The MHRA can request the <strong>PMS Plan<\/strong> and, if applicable, the <strong>PSUR <\/strong>(Periodic Safety Update Report) at any time.<\/li>\n<li>Documents must be made available <strong>within 3 working days upon request of the authority<\/strong><\/li>\n<\/ul>\n<h2>4. MORE system: mandatory digital reporting<\/h2>\n<p>All reports must be submitted via the <strong>Manufacturer Online Reporting Environment (MORE)<\/strong> The portal supports the sending of<\/p>\n<ul>\n<li>Accident information, such as Manufacturer Incident Reports (MIR).<\/li>\n<li>Survey results.<\/li>\n<li>Corrective actions taken.<\/li>\n<\/ul>\n<p>The MHRA has published useful\u00a0<a href=\"https:\/\/www.gov.uk\/government\/publications\/more-implementation\/gb-mir-and-fsca-schema-implementation-guide\">Guidelines<\/a>\u00a0on the use of XML files (XSD) for MIR and FSCA reports in the MORE system, valid for Great Britain.<\/p>\n<h2><strong>UK Responsible Person: more responsibility<\/strong><\/h2>\n<p>The responsibilities of the <strong>UK Responsible<\/strong> <strong>Person (UKRP)<\/strong> expand and become crucial to the proper management of Post-Market Surveillance of Medical Devices in Great Britain. The UKRP must request, maintain and monitor the <strong>PMS<\/strong> <strong>plans<\/strong> and any <strong>PSURs<\/strong> of the manufacturers it represents, ensuring compliance. In addition, <strong>manufacturers<\/strong> are obliged to inform the UKRP of any <strong>importer operating<\/strong> in the UK and to report any new appointment or removal promptly.<\/p>\n<h2><strong>Conclusions and Implications for Manufacturers<\/strong><\/h2>\n<p>The new Post-Market Surveillance framework for Medical Devices in Great Britain, introduced by the <em>Medical Devices (Amendment) 2024,<\/em> aims to close historical gaps with a more rigorous approach. Although inspired by international best practice and European regulations, significant differences remain, so a strategic approach is needed, combining international harmonisation and specific adaptation to British standards.<\/p>\n<p>Medical device manufacturers must adapt to the new regulations promptly in order to maintain their presence in the UK market.<\/p>\n<p><strong>&gt;&gt;&gt; <\/strong>For support in compliance with Great Britain regulations, Thema, as <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/servizio-di-uk-responsible-person\/\"><strong>UK Responsible Person<\/strong><\/a>, offers <a href=\"m\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\">strategic regulatory consulting<\/a> throughout the medical device lifecycle, including the Post-Market Surveillance phase.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Useful sources and resources:<\/strong><\/p>\n<p><a href=\"https:\/\/www.gov.uk\/government\/publications\/more-implementation\/gb-mir-and-fsca-schema-implementation-guide\">GB MIR and FSCA scheme implementation guide &#8211; GOV.UK<\/a><\/p>\n<p><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\">The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation &#8211; GOV.UK<\/a><\/p>\n<p><a href=\"https:\/\/www.gov.uk\/government\/publications\/medical-devices-post-market-surveillance-requirements\/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes\">Post-market surveillance requirements for medical devices: summary of main changes &#8211; GOV.UK<\/a><\/p>\n<p><a href=\"https:\/\/www.gov.uk\/government\/publications\/more-implementation\/gb-mir-and-fsca-schema-implementation-guide\">GB MIR and FSCA schema implementation guide<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><em>06\/10\/2025<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Post-market surveillance (PMS) of medical devices in Great Britain plays a key role in ensuring user safety and compliance. With the  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