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MHRA PMS compliance: Everything UK MedTech manufacturers need to know",[207,210],{"path":203,"langcode":208},{"id":209},"en",{"path":211,"langcode":212},"\u002Fde\u002Finsights\u002Fnavigating-mhra-pms-compliance-uk-medtech",{"id":213},"de",{"id":215,"sharedMediaLegend":204,"mediaImage":216,"name":241},"172199",{"url":217,"width":218,"height":219,"alt":220,"title":204,"size":221,"mime":222,"variations":204,"headerMinimalVariations":223},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fimages\u002Fpost-market-surveillance.jpg",1920,1280,"\"\"",366227,"image\u002Fjpeg",[224,229,230,235,240],{"name":225,"url":226,"width":227,"height":228},"FOCAL_POINT32_SMALL","https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_3_2_small\u002Fpublic\u002Fimages\u002Fpost-market-surveillance.jpg.webp?itok=WDSU9jKz",800,533,{"name":225,"url":226,"width":227,"height":228},{"name":231,"url":232,"width":233,"height":234},"FOCAL_POINT169_MEDIUM","https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_16_9_medium\u002Fpublic\u002Fimages\u002Fpost-market-surveillance.jpg.webp?itok=rpIdTSni",1200,675,{"name":236,"url":237,"width":238,"height":239},"FOCAL_POINT169_LARGE","https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_16_9_large\u002Fpublic\u002Fimages\u002Fpost-market-surveillance.jpg.webp?itok=IuNWebM2",1600,900,{"name":236,"url":237,"width":238,"height":239},"post-market-surveillance.jpg",{"processed":243},"\u003Cp>\u003Cspan lang=\"EN-GB\">As of 16 June 2025, the UK has officially implemented a new regulatory framework for medical device Post-Market Surveillance (PMS), marking a significant shift in how manufacturers must now monitor and report on the safety and performance of their products. &nbsp;((update))\u003C\u002Fspan>\u003C\u002Fp>",{"id":215,"sharedMediaLegend":204,"mediaImage":245,"name":241},{"url":217,"width":218,"height":219,"alt":220,"title":204,"size":221,"mime":222,"variations":204},[247,253,282,286,312,317,321,354,360],{"__typename":248,"id":249,"ctaLink":204,"pgSharedText":250,"pgSharedTitle":204,"pgSharedCtaLink":204},"ParagraphPgText","32693",{"value":251,"processed":251,"format":252},"\u003Cp>This change – introduced through the \u003Ca href=\"https:\u002F\u002Fwww.gov.uk\u002Fgovernment\u002Fpublications\u002Fmedical-devices-post-market-surveillance-requirements\" target=\"_blank\">Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024\u003C\u002Fa> – is more than just a regulatory update. It’s a call to action for manufacturers to adopt a proactive, data-driven approach to compliance, safety and innovation.\u003C\u002Fp>","full_html",{"__typename":254,"id":255,"columns":256,"listItems":257,"text":279,"title":280,"variant":281},"ParagraphPgContentList","32698","2col",[258,264,269,274],{"id":259,"icon":204,"link":204,"logo":204,"media":204,"text":260,"title":263},"32694",{"value":261,"processed":261,"format":262},"\u003Cp>Manufacturers must maintain a written PMSP for all devices, outlining how they will systematically collect, assess and act on post-market data (Reg. 44ZE).\u003C\u002Fp>","content_list","Mandatory PMS Plans (PMSP): ",{"id":265,"icon":204,"link":204,"logo":204,"media":204,"text":266,"title":268},"32695",{"value":267,"processed":267,"format":262},"\u003Cp>Depending on device risk class, manufacturers must submit either a Post-Market Surveillance Report (PMSR) for low-risk devices or a more detailed Periodic Safety Update Report (PSUR) for higher-risk devices classified as Class IIa, IIb, and III (Reg. 44ZM).\u003C\u002Fp>","Regular, risk-based reporting: ",{"id":270,"icon":204,"link":204,"logo":204,"media":204,"text":271,"title":273},"32696",{"value":272,"processed":272,"format":262},"\u003Cp>Serious incidents must now be reported within 15 working days, a significant reduction from the previous 30-day window (Reg. 44ZH).\u003C\u002Fp>","Faster incident reporting:",{"id":275,"icon":204,"link":204,"logo":204,"media":204,"text":276,"title":278},"32697",{"value":277,"processed":277,"format":262},"\u003Cp>All vigilance reporting must be done via the \u003Ca href=\"https:\u002F\u002Fwww.gov.uk\u002Fgovernment\u002Forganisations\u002Fmedicines-and-healthcare-products-regulatory-agency\">Medicines &amp; Healthcare products Regulatory Agency (MHRA)’s\u003C\u002Fa> new Manufacturer’s Online Reporting Environment (MORE) platform (Reg. 44ZI). This move toward a centralised, digital system mirrors the approach of established international bodies – like the \u003Ca href=\"https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fhuman-regulatory-overview\u002Fresearch-development\u002Fpharmacovigilance-research-development\u002Feudravigilance\">EU's EudraVigilance\u003C\u002Fa> – which use standardised electronic reporting for early signal detection and robust safety monitoring.\u003C\u002Fp>","Digital vigilance:","These updated PMS requirements apply to all CE and UKCA-marked medical devices in the GB market, including in vitro diagnostics and active implantable devices.\r\n\r\nAt its core, the framework mandates that PMS must become a proactive process designed to collect and review data from in-use devices – rather than a case of reacting to incidents as they occur. This process must be fully integrated into the manufacturer's overarching Quality Management System (QMS).\r\n\r\nKey obligations include:","What does the MHRA PMS regulation mean?","icon",{"__typename":248,"id":283,"ctaLink":204,"pgSharedText":284,"pgSharedTitle":204,"pgSharedCtaLink":204},"32699",{"value":285,"processed":285,"format":252},"\u003Cp>These changes aim to enhance patient safety, increase transparency and align UK standards more closely with global best practices.\u003C\u002Fp>",{"__typename":287,"id":288,"caption":204,"imageRight":289,"pgSharedTitle":290,"pgSharedCtaLink":204,"textMedia":291,"pgSharedText":310},"ParagraphPgTextMedia","32727",false,"The business impact: Risk, complexity and opportunity",{"id":292,"sharedMediaLegend":204,"mediaImage":293,"name":309},"172216",{"url":294,"width":219,"height":295,"alt":220,"title":204,"size":296,"mime":222,"variations":204,"textMediaVariations":297},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fimages\u002Fbusiness-impact-post-market-surveillance.jpg",857,185982,[298,302,303,304,308],{"name":299,"url":300,"width":239,"height":301},"FIXED_WIDTH_SMALL","https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffixed_width_small\u002Fpublic\u002Fimages\u002Fbusiness-impact-post-market-surveillance.jpg.webp?itok=GqT_ucOz",603,{"name":299,"url":300,"width":239,"height":301},{"name":299,"url":300,"width":239,"height":301},{"name":305,"url":306,"width":233,"height":307},"FIXED_WIDTH_MEDIUM","https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffixed_width_medium\u002Fpublic\u002Fimages\u002Fbusiness-impact-post-market-surveillance.jpg.webp?itok=DBsEDLqi",803,{"name":305,"url":306,"width":233,"height":307},"business-impact-post-market-surveillance.jpg",{"value":311,"processed":311,"format":252},"\u003Cp>For many organisations, especially SMEs and scale-ups, these new requirements introduce significant operational and technical challenges.\u003C\u002Fp>\u003Cp>Inefficient post-market processes can be a major resource drain, and that can have knock-on effects on agility, safety and compliance.\u003C\u002Fp>",{"__typename":248,"id":313,"ctaLink":204,"pgSharedText":314,"pgSharedTitle":204,"pgSharedCtaLink":204},"32728",{"value":315,"processed":316,"format":252},"\u003Cp>Key pressures here include:\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cstrong>Increased compliance overhead:\u003C\u002Fstrong> The need for detailed PMS Plans and periodic reports for all devices requires dedicated resources and expertise.\u003C\u002Fli>\u003Cli>\u003Cstrong>Need for robust data infrastructure:\u003C\u002Fstrong> Tracking device performance in real time requires more than spreadsheets; it demands a secure and scalable \u003Ca href=\"\u002Fnode\u002F6647\" data-entity-type=\"node\" data-entity-uuid=\"685fea0a-4ce0-4b5d-ba0f-6fb137f51971\" data-entity-substitution=\"canonical\">data infrastructure.\u003C\u002Fa>\u003C\u002Fli>\u003Cli>\u003Cstrong>Pressure to align with UK-specific reporting:\u003C\u002Fstrong> While the new UK rules are similar to the EU MDR, they’re not identical. One key difference lies in the scope of reporting; EU MDR requires broader market intelligence, including safety data from similar devices by other manufacturers and consideration of the evolving technological landscape.&nbsp;\u003C\u002Fli>\u003C\u002Ful>","\u003Cp>Key pressures here include:\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cstrong>Increased compliance overhead:\u003C\u002Fstrong> The need for detailed PMS Plans and periodic reports for all devices requires dedicated resources and expertise.\u003C\u002Fli>\u003Cli>\u003Cstrong>Need for robust data infrastructure:\u003C\u002Fstrong> Tracking device performance in real time requires more than spreadsheets; it demands a secure and scalable \u003Ca href=\"\u002Fen\u002Fexpertise\u002Fdata-solutions\" data-entity-type=\"node\" data-entity-uuid=\"685fea0a-4ce0-4b5d-ba0f-6fb137f51971\" data-entity-substitution=\"canonical\" title=\"EXPERTISE: Data solutions (EN)\">data infrastructure.\u003C\u002Fa>\u003C\u002Fli>\u003Cli>\u003Cstrong>Pressure to align with UK-specific reporting:\u003C\u002Fstrong> While the new UK rules are similar to the EU MDR, they’re not identical. One key difference lies in the scope of reporting; EU MDR requires broader market intelligence, including safety data from similar devices by other manufacturers and consideration of the evolving technological landscape.&nbsp;\u003C\u002Fli>\u003C\u002Ful>",{"__typename":248,"id":318,"ctaLink":204,"pgSharedText":319,"pgSharedTitle":204,"pgSharedCtaLink":204},"32704",{"value":320,"processed":320,"format":252},"\u003Cp>In contrast, the UK PMS framework focuses more narrowly on device-specific data from the GB market, and does not mandate inclusion of competitor data or external benchmarks. This divergence prevents a simple \"copy and paste\" of compliance strategies and calls instead for a modular PMS approach – one that supports deeper reporting in EU submissions and streamlined processes for UKCA-marked devices. The push for real-world evidence is a global trend, with other major regulators like the US FDA also mandating robust post-market data collection for many devices.\u003C\u002Fp>\u003Cp>However, these challenges also create opportunities. For companies that embed a proactive and efficient compliance strategy into their innovation lifecycle, these regulations can become a source of competitive advantage.\u003C\u002Fp>\u003Cp>It's also critical to note that these changes are a sign of what’s to come, with \u003Ca href=\"https:\u002F\u002Fwww.hoganlovells.com\u002Fen\u002Fpublications\u002Fbe-vigilant-new-postmarket-surveillance-requirements-for-medical-devices-in-great-britain\" target=\"_blank\">future UK regulations expected for areas like software\u002FAI and Unique Device Identification (UDI).\u003C\u002Fa>\u003C\u002Fp>",{"__typename":322,"id":323,"title":324,"lead":204,"tabs":325},"ParagraphTab","32716","Your immediate compliance checklist",[326,333,340,347],{"infoText":327,"pgSharedParagraphs":328},"1. Confirm MORE platform access",[329],{"id":330,"ctaLink":204,"pgSharedText":331,"pgSharedTitle":327,"pgSharedCtaLink":204},"32708",{"value":332,"processed":332,"format":252},"\u003Cp>Ensure your designated regulatory contact is successfully registered on the MHRA's MORE platform.\u003C\u002Fp>",{"infoText":334,"pgSharedParagraphs":335},"2. Audit your portfolio",[336],{"id":337,"ctaLink":204,"pgSharedText":338,"pgSharedTitle":334,"pgSharedCtaLink":204},"32710",{"value":339,"processed":339,"format":252},"\u003Cp>Classify every device on the GB market to determine its reporting requirement (PMSR vs. PSUR) under the new framework.\u003C\u002Fp>",{"infoText":341,"pgSharedParagraphs":342},"3. Assess your data systems",[343],{"id":344,"ctaLink":204,"pgSharedText":345,"pgSharedTitle":341,"pgSharedCtaLink":204},"32712",{"value":346,"processed":346,"format":252},"\u003Cp>Evaluate your current ability to collect, aggregate, and analyse post-market data in a scalable and timely manner.\u003C\u002Fp>",{"infoText":348,"pgSharedParagraphs":349},"4. Map your strategy",[350],{"id":351,"ctaLink":204,"pgSharedText":352,"pgSharedTitle":348,"pgSharedCtaLink":204},"32714",{"value":353,"processed":353,"format":252},"\u003Cp>\u003Cspan lang=\"EN-GB\">Define a clear roadmap for integrating PMS into your QMS and turning compliance data into actionable insights.\u003C\u002Fspan>\u003C\u002Fp>",{"__typename":248,"id":355,"ctaLink":204,"pgSharedText":356,"pgSharedTitle":359,"pgSharedCtaLink":204},"32718",{"value":357,"processed":358,"format":252},"\u003Cp>At Zühlke, we understand that compliance is not just a checkbox. When done right, it’s a competitive advantage. With deep expertise in regulated industries like HealthTech, we help organisations navigate the highly-specific challenges posed by an ever-evolving regulatory landscape.\u003C\u002Fp>\u003Cp>Health industry leaders already recognise that technology is critical when it comes to compliance, with 70% reporting that \u003Ca href=\"https:\u002F\u002Fwww.pwc.de\u002Fde\u002Frisk-regulatory\u002Fglobal-compliance-survey\u002Fpwc-global-compliance-study-2025-health-industry-lens.pdf\">it provides better visibility of risks and 51% confirming it enables a faster response to issues.\u003C\u002Fa>\u003C\u002Fp>\u003Cp>We help organisations:\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cstrong>Design and implement PMS-ready systems\u003C\u002Fstrong> that automate data collection and reporting – ensuring they are integrated directly into your Quality Management System, as expected by approved bodies.\u003C\u002Fli>\u003Cli>\u003Cstrong>Integrate AI-driven monitoring tools\u003C\u002Fstrong> to detect safety signals and trends early.\u003C\u002Fli>\u003Cli>\u003Ca href=\"\u002Fnode\u002F5542\" data-entity-type=\"node\" data-entity-uuid=\"1e7b700a-624c-4908-9e05-3707c4c853eb\" data-entity-substitution=\"canonical\">\u003Cstrong>Build digital platforms\u003C\u002Fstrong>\u003C\u002Fa> that are secure, scalable and compliant with MHRA and international standards.\u003C\u002Fli>\u003Cli>\u003Cstrong>Navigate regulatory complexity\u003C\u002Fstrong> with multidisciplinary teams that combine engineering, strategy and emergent technology skills that modern compliance demands.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>In addition, Zühlke helps companies streamline PSUR reporting workflows (as required under Reg. 44ZM), detect safety trends early through AI-supported analysis (Reg. 44ZN) and ensure readiness through regulatory gap assessments aligned with both UK MDR (Reg. 44ZE) and ISO 13485.\u003C\u002Fp>\u003Cp>For manufacturers developing software or AI-based medical technologies, we also support digital health compliance in line with IEC 62304 – anticipating future guidance for SaMD and AI\u002FML systems in the UK.\u003C\u002Fp>\u003Cp>So, whether you're launching a new device or modernising legacy systems, Zühlke offers end-to-end support – from concept to compliance and beyond.\u003C\u002Fp>","\u003Cp>At Zühlke, we understand that compliance is not just a checkbox. When done right, it’s a competitive advantage. With deep expertise in regulated industries like HealthTech, we help organisations navigate the highly-specific challenges posed by an ever-evolving regulatory landscape.\u003C\u002Fp>\u003Cp>Health industry leaders already recognise that technology is critical when it comes to compliance, with 70% reporting that \u003Ca href=\"https:\u002F\u002Fwww.pwc.de\u002Fde\u002Frisk-regulatory\u002Fglobal-compliance-survey\u002Fpwc-global-compliance-study-2025-health-industry-lens.pdf\">it provides better visibility of risks and 51% confirming it enables a faster response to issues.\u003C\u002Fa>\u003C\u002Fp>\u003Cp>We help organisations:\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cstrong>Design and implement PMS-ready systems\u003C\u002Fstrong> that automate data collection and reporting – ensuring they are integrated directly into your Quality Management System, as expected by approved bodies.\u003C\u002Fli>\u003Cli>\u003Cstrong>Integrate AI-driven monitoring tools\u003C\u002Fstrong> to detect safety signals and trends early.\u003C\u002Fli>\u003Cli>\u003Ca href=\"\u002Fen\u002Finsights\u002Fwhy-digital-health-platforms-are-vital-for-data-driven-life-sciences-and-healthcare\" data-entity-type=\"node\" data-entity-uuid=\"1e7b700a-624c-4908-9e05-3707c4c853eb\" data-entity-substitution=\"canonical\" title=\"Why Digital Health Platforms are vital for data-driven life sciences and healthcare organizations\">\u003Cstrong>Build digital platforms\u003C\u002Fstrong>\u003C\u002Fa> that are secure, scalable and compliant with MHRA and international standards.\u003C\u002Fli>\u003Cli>\u003Cstrong>Navigate regulatory complexity\u003C\u002Fstrong> with multidisciplinary teams that combine engineering, strategy and emergent technology skills that modern compliance demands.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>In addition, Zühlke helps companies streamline PSUR reporting workflows (as required under Reg. 44ZM), detect safety trends early through AI-supported analysis (Reg. 44ZN) and ensure readiness through regulatory gap assessments aligned with both UK MDR (Reg. 44ZE) and ISO 13485.\u003C\u002Fp>\u003Cp>For manufacturers developing software or AI-based medical technologies, we also support digital health compliance in line with IEC 62304 – anticipating future guidance for SaMD and AI\u002FML systems in the UK.\u003C\u002Fp>\u003Cp>So, whether you're launching a new device or modernising legacy systems, Zühlke offers end-to-end support – from concept to compliance and beyond.\u003C\u002Fp>","How Zühlke can help: Your partner for compliant innovation",{"__typename":287,"id":361,"caption":204,"imageRight":289,"pgSharedTitle":362,"pgSharedCtaLink":204,"textMedia":363,"pgSharedText":382},"32719","Let’s build what’s next – safely and strategically",{"id":364,"sharedMediaLegend":204,"mediaImage":365,"name":381},"172110",{"url":366,"width":367,"height":368,"alt":369,"title":204,"size":370,"mime":222,"variations":204,"textMediaVariations":371},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fimages\u002Fdigital-strategy-consulting-3.jpg",1498,1000,"Digital Strategy Consulting",121491,[372,375,376,377,380],{"name":299,"url":373,"width":239,"height":374},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffixed_width_small\u002Fpublic\u002Fimages\u002Fdigital-strategy-consulting-3.jpg.webp?itok=3S5UgJ8l",601,{"name":299,"url":373,"width":239,"height":374},{"name":299,"url":373,"width":239,"height":374},{"name":305,"url":378,"width":233,"height":379},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffixed_width_medium\u002Fpublic\u002Fimages\u002Fdigital-strategy-consulting-3.jpg.webp?itok=JyajH4oj",801,{"name":305,"url":378,"width":233,"height":379},"digital-strategy-consulting-3.jpg",{"value":383,"processed":384,"format":252},"\u003Cp>The UK’s new PMS regulations are a pivotal moment for the HealthTech sector. They demand more than compliance – they demand innovation built upon resilience, agility and foresight.\u003C\u002Fp>\u003Cp>At Zühlke, we don’t just help you meet ever-evolving standards. We help you set them.\u003C\u002Fp>\u003Cp>🔗&nbsp;\u003Cstrong>Learn more about our work in regulated industries like\u003C\u002Fstrong>\u003Cspan lang=\"EN-GB\">\u003Cstrong> \u003C\u002Fstrong>\u003C\u002Fspan>\u003Ca href=\"\u002Fnode\u002F26275\" data-entity-type=\"node\" data-entity-uuid=\"5bb11bd1-0449-4cc6-95e0-c53bfa7cddbb\" data-entity-substitution=\"canonical\">\u003Cspan lang=\"EN-GB\">\u003Cstrong>Healthcare\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan lang=\"EN-GB\">\u003Cstrong> or&nbsp;\u003C\u002Fstrong>\u003C\u002Fspan>\u003Ca href=\"\u002Fnode\u002F26272\" data-entity-type=\"node\" data-entity-uuid=\"fbdb1630-8e7c-4ee2-9034-ed75c9bf2d2b\" data-entity-substitution=\"canonical\">\u003Cspan lang=\"EN-GB\">\u003Cstrong>MedTech\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan lang=\"EN-GB\">\u003Cstrong>. \u003C\u002Fstrong>\u003C\u002Fspan>\u003Cspan lang=\"EN-GB\">\u003C\u002Fspan>\u003C\u002Fp>","\u003Cp>The UK’s new PMS regulations are a pivotal moment for the HealthTech sector. They demand more than compliance – they demand innovation built upon resilience, agility and foresight.\u003C\u002Fp>\u003Cp>At Zühlke, we don’t just help you meet ever-evolving standards. We help you set them.\u003C\u002Fp>\u003Cp>🔗&nbsp;\u003Cstrong>Learn more about our work in regulated industries like\u003C\u002Fstrong>\u003Cspan lang=\"EN-GB\">\u003Cstrong> \u003C\u002Fstrong>\u003C\u002Fspan>\u003Ca href=\"\u002Fen\u002Findustries\u002Fhealthcare-providers\" data-entity-type=\"node\" data-entity-uuid=\"5bb11bd1-0449-4cc6-95e0-c53bfa7cddbb\" data-entity-substitution=\"canonical\" title=\"INDUSTRY: Healthcare providers (EN)\">\u003Cspan lang=\"EN-GB\">\u003Cstrong>Healthcare\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan lang=\"EN-GB\">\u003Cstrong> or&nbsp;\u003C\u002Fstrong>\u003C\u002Fspan>\u003Ca href=\"\u002Fen\u002Findustries\u002Fmedtech\" data-entity-type=\"node\" data-entity-uuid=\"fbdb1630-8e7c-4ee2-9034-ed75c9bf2d2b\" data-entity-substitution=\"canonical\" title=\"INDUSTRY: MedTech (EN)\">\u003Cspan lang=\"EN-GB\">\u003Cstrong>MedTech\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan lang=\"EN-GB\">\u003Cstrong>. \u003C\u002Fstrong>\u003C\u002Fspan>\u003Cspan lang=\"EN-GB\">\u003C\u002Fspan>\u003C\u002Fp>",[386],{"id":387,"name":388},"13","MedTech",[390,393,396,399],{"id":391,"name":392},"875","Data",{"id":394,"name":395},"876","Data strategy",{"id":397,"name":398},"20","Hardware engineering",{"id":400,"name":401},"21","Software engineering",{"processed":403},"\u003Cp>As of 16 June 2025, the UK has officially implemented a new regulatory framework for medical device Post-Market Surveillance (PMS), marking a significant shift in how manufacturers must now monitor and report on the safety and performance of their products.\u003C\u002Fp>\n",{"timestamp":405},1756728000,[407],{"status":7,"contactName":408,"contactProfession":409,"contactLinkedinUrl":204,"sharedEmail":204,"sharedRefMedia":410},"Simon Christopher","Former Director Med-Tech\u002F Health-Tech Business",{"id":411,"sharedMediaLegend":204,"mediaImage":412,"name":426},"172215",{"url":413,"width":414,"height":414,"alt":415,"title":204,"size":416,"mime":417,"variations":204,"authorVariations":418},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fimages\u002FSimon-Christopher-Zuhlke.png",772,"portrait photo of Simon Christopher, Director Med-Tech\u002F Health-Tech Business at Zühlke",717066,"image\u002Fpng",[419,422,423,424,425],{"name":420,"url":421,"width":414,"height":414},"FOCAL_POINT11_SMALL","https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_1_1_small\u002Fpublic\u002Fimages\u002FSimon-Christopher-Zuhlke.png.webp?itok=aeafLt0L",{"name":420,"url":421,"width":414,"height":414},{"name":420,"url":421,"width":414,"height":414},{"name":420,"url":421,"width":414,"height":414},{"name":420,"url":421,"width":414,"height":414},"Simon-Christopher-Zuhlke.png",[428,462,487,521],{"id":429,"path":430,"sharedTeaserTitle":431,"sharedTeaserRefMedia":432,"sharedTaxrefIndustries":450,"sharedTaxrefExpertises":454},"26286","\u002Fen\u002Finsights\u002Fdeepseek-and-the-rise-of-open-source-ai-a-game-changer-for-businesses","DeepSeek & open-source AI: A game-changer for business?",{"id":433,"sharedMediaLegend":204,"mediaImage":434,"name":449},"171116",{"url":435,"width":436,"height":437,"alt":220,"title":204,"size":438,"mime":222,"variations":204,"relatedContentVariations":439},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fimages\u002Fdeepseek-genai.jpg",640,448,183670,[440,443,444,447,448],{"name":225,"url":441,"width":436,"height":442},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_3_2_small\u002Fpublic\u002Fimages\u002Fdeepseek-genai.jpg.webp?itok=eefhmU5B",427,{"name":225,"url":441,"width":436,"height":442},{"name":445,"url":446,"width":436,"height":442},"FOCAL_POINT32_MEDIUM","https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_3_2_medium\u002Fpublic\u002Fimages\u002Fdeepseek-genai.jpg.webp?itok=3cLKyagI",{"name":445,"url":446,"width":436,"height":442},{"name":445,"url":446,"width":436,"height":442},"deepseek-genai.jpg",[451],{"id":452,"name":453},"855","All industries",[455,458,461],{"id":456,"name":457},"110","AI",{"id":459,"name":460},"874","GenAI",{"id":391,"name":392},{"id":463,"path":464,"sharedTeaserTitle":465,"sharedTeaserRefMedia":466,"sharedTaxrefIndustries":482,"sharedTaxrefExpertises":484},"6960","\u002Fen\u002Finsights\u002Fhow-far-are-you-on-the-path-to-becoming-a-data-driven-company","How far are you on the path to becoming a data-driven company?",{"id":467,"sharedMediaLegend":204,"mediaImage":468,"name":481},"6287",{"url":469,"width":219,"height":470,"alt":471,"title":204,"size":472,"mime":222,"variations":204,"relatedContentVariations":473},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fimages\u002Fzuhlke-data-driven-company.jpg",854,"data-driven company ",216630,[474,476,477,479,480],{"name":225,"url":475,"width":227,"height":228},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_3_2_small\u002Fpublic\u002Fimages\u002Fzuhlke-data-driven-company.jpg.webp?itok=Mg-z1iDx",{"name":225,"url":475,"width":227,"height":228},{"name":445,"url":478,"width":233,"height":227},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_3_2_medium\u002Fpublic\u002Fimages\u002Fzuhlke-data-driven-company.jpg.webp?itok=je6goP6M",{"name":445,"url":478,"width":233,"height":227},{"name":445,"url":478,"width":233,"height":227},"zuhlke-data-driven-company.jpg",[483],{"id":452,"name":453},[485,486],{"id":391,"name":392},{"id":394,"name":395},{"id":488,"path":489,"sharedTeaserTitle":490,"sharedTeaserRefMedia":491,"sharedTaxrefIndustries":509,"sharedTaxrefExpertises":513},"649","\u002Fen\u002Finsights\u002Fwhy-a-data-driven-culture-is-essential-for-todays-insurers","Why a data-driven culture is essential for today’s insurers",{"id":492,"sharedMediaLegend":204,"mediaImage":493,"name":508},"428",{"url":494,"width":495,"height":496,"alt":497,"title":204,"size":498,"mime":222,"variations":204,"relatedContentVariations":499},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fimages\u002Finsurance_big_data.jpg",693,520,"Big Data in Insurance ",210547,[500,503,504,506,507],{"name":225,"url":501,"width":495,"height":502},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_3_2_small\u002Fpublic\u002Fimages\u002Finsurance_big_data.jpg.webp?itok=jM1ajCTd",462,{"name":225,"url":501,"width":495,"height":502},{"name":445,"url":505,"width":495,"height":502},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_3_2_medium\u002Fpublic\u002Fimages\u002Finsurance_big_data.jpg.webp?itok=T1mmdL82",{"name":445,"url":505,"width":495,"height":502},{"name":445,"url":505,"width":495,"height":502},"insurance_big_data.jpg",[510],{"id":511,"name":512},"11","Insurance",[514,515,518],{"id":391,"name":392},{"id":516,"name":517},"19","Digital strategy",{"id":519,"name":520},"886","Tech innovation",{"id":202,"path":203,"sharedTeaserTitle":205,"sharedTeaserRefMedia":522,"sharedTaxrefIndustries":531,"sharedTaxrefExpertises":533},{"id":215,"sharedMediaLegend":204,"mediaImage":523,"name":241},{"url":217,"width":218,"height":219,"alt":220,"title":204,"size":221,"mime":222,"variations":204,"relatedContentVariations":524},[525,526,527,529,530],{"name":225,"url":226,"width":227,"height":228},{"name":225,"url":226,"width":227,"height":228},{"name":445,"url":528,"width":233,"height":227},"https:\u002F\u002Fcms.zuehlke.com\u002Fsites\u002Fdefault\u002Ffiles\u002Fstyles\u002Ffocal_point_3_2_medium\u002Fpublic\u002Fimages\u002Fpost-market-surveillance.jpg.webp?itok=954ZaywU",{"name":445,"url":528,"width":233,"height":227},{"name":445,"url":528,"width":233,"height":227},[532],{"id":387,"name":388},[534,535,536,537],{"id":391,"name":392},{"id":394,"name":395},{"id":397,"name":398},{"id":400,"name":401}]