UK MHRA News!! (Post-market Surveillance (PMS)) Today (20- December), the UK has published a new Statutory Instrument "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024" The Draft Statutory Instrument published in October 2024 has now been made. These regulations enhance post-market surveillance systems, clarify reporting obligations, and strengthen manufacturers' accountability for devices placed on the market in Great Britain. Key Updates: • Updates definitions that will apply for the purposes of post-market surveillance (PMS). • Manufacturers must establish a post-market surveillance system, which should be based on a PMS plan. • PMS Reports (PMSR) required for low-risk devices and updated every three years. • Periodic Safety Update Reports (PSURs) required for medium and high-risk devices (updated every two years or annually for high-risk devices) • Manufacturers must retain PMS documentation for at least 10 years after the last device is placed on the market (15 years for implantable devices). The PMS Regulations come into force 6 months from the day the regulations were made. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us at MedBoard #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #ivdr #mdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #pms #mhra #fsca
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UK MHRA News!! (Post-market Surveillance (PMS)) The UK MHRA has published a new draft Statutory Instrument "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024" This Statutory Instrument amends the Medical Devices Regulations 2002 (S.I. 2002/618) (“the 2002 Regulations”) to insert new post-market surveillance requirements. This amendment introduces stricter surveillance obligations on manufacturers to ensure continuous monitoring of their devices’ performance, safety, and quality after they are placed on the market. The Draft amendment includes: • Updates definitions that will apply for the purposes of post-market surveillance (PMS). • Contains new PMS requirements for devices and accessories that are placed on the market or put into service in Great Britain. • Manufacturers must establish a post-market surveillance system, which should be based on a PMS plan. • Outlines requirements for manufacturers to take preventive and corrective actions, includes field safety corrective actions (FSCA). • Imposes investigation and reporting requirements on manufacturers in relation to serious incidents and trends in incidents. • Provides for the retention of the documentation produced by a manufacturer. The draft amendments will apply to devices placed on the market after the regulation's enforcement date. However, existing requirements will still apply to devices placed on the market before the enforcement. For more MedTech, Pharma, BioTech News, Regulatory Intelligence, PMS automation, Clinical Literature automation, Research, Intelligence and much more, log onto www.medboard.com or contact us. #intelligence #notifiedbody #notifiedbodies #audit #medboard #medicaldevices #medtech #ivdr #mdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #pms #mhra #fsca
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🌟Enhancing Post-Market Surveillance for Medical Devices 🌟 Post-Market Surveillance (PMS) is a critical component of ensuring the long-term safety and efficacy of medical devices. Effective PMS strategies allow us to systematically collect and analyze data on device performance in the real world, identify potential issues early, and implement necessary corrective actions. This ongoing vigilance not only ensures regulatory compliance but also continuously improves our products, ultimately enhancing patient outcomes. 🔍 Project Highlight: Amplatzer Amulet Left Atrial Appendage Occluder (LAAO) by Abbott During my academic tenure at Northeastern University, I had the opportunity to work on a comprehensive Post-Market Surveillance Plan for Abbott's Amplatzer Amulet Left Atrial Appendage Occluder, a device designed to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Here are some key aspects of my contribution: Risk Assessments: Conducted thorough risk assessments to identify potential issues with the device and implemented mitigation strategies to address these risks. Compliance: Ensured adherence to regulatory requirements and standards, including FDA regulations and ISO 13485, throughout the post-market phase. Data Analysis: Analyzed post-market data to identify trends and patterns, generating reports and recommendations for continuous improvement of the device. Surveillance Plan: Developed a detailed post-market surveillance plan to monitor the device's performance and safety, including the collection and analysis of complaint data and adverse events. This project not only enhanced my understanding of PMS but also underscored the importance of continuous monitoring and proactive risk management in maintaining device safety and efficacy. #PostMarketSurveillance #MedicalDevices #RegulatoryAffairs #QualityManagement #PatientSafety #AmplatzerAmulet #Abbott #FDA #ISO13485 #HealthcareInnovation #NortheasternUniversity Image Link - https://lnkd.in/ef9sv7H2
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#PMS #PostMarketSurvellience #medicaldevices #UK #Regulatory Important information to monitory for all as it pertains to PMS and #reguluatoryaffairs
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Big news in the UK today! The Post-market Surveillance (PMS) Statutory instrument (SI) laid in Parliament yesterday evening is the first major update to the framework of medical device regulations in Great Britain, led by the Medicines and Healthcare products Regulatory Agency (MHRA). The key changes within the final draft PMS SI include: ✅️ Details on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers. ✅️ Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner. ✅️ Clearer obligations on manufacturers to consider conducting a Field Safety Corrective Action (FSCA) to prevent or reduce the risk of a further serious incident. Accompanied by detailed requirements relating to Field Safety Notices (FSN) to better target patients and users at risk. ✅️ More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device. The draft PMS SI will be debated in Parliament and is expected to come into force in the Summer of 2025 following a 6-month implementation period. #postmarketsurveillance #MHRA #United Kingdom #medtech #newlegislation #medical devices #ivds #incident reporting #PSUR #FSCA #FSN #pmsp #pmsr #trendreport
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Big news in the UK today! The Post-market Surveillance (PMS) Statutory instrument (SI) laid in Parliament yesterday evening is the first major update to the framework of medical device regulations in Great Britain, led by the Medicines and Healthcare products Regulatory Agency (MHRA). The key changes within the final draft PMS SI include: ✅️ Details on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers. ✅️ Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner. ✅️ Clearer obligations on manufacturers to consider conducting a Field Safety Corrective Action (FSCA) to prevent or reduce the risk of a further serious incident. Accompanied by detailed requirements relating to Field Safety Notices (FSN) to better target patients and users at risk. ✅️ More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device. The draft PMS SI will be debated in Parliament and is expected to come into force in the Summer of 2025 following a 6-month implementation period. #postmarketsurveillance #MHRA #United Kingdom #medtech #newlegislation #medical devices #ivds #incident reporting #PSUR #FSCA #FSN #pmsp #pmsr #trendreport
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🚨 UK MHRA Update: Key Changes to Post-market Surveillance (PMS) for Medical Devices 🚨 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has just released a draft Statutory Instrument: "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024." This amendment introduces critical updates to the Medical Devices Regulations 2002 (S.I. 2002/618) that will impact manufacturers and the oversight of devices on the market. What’s new? 📋 New, clearer definitions for Post-market Surveillance (PMS) 🔎 Stricter PMS requirements for devices & accessories in Great Britain 🛠️ Mandatory PMS systems based on detailed PMS plans ⚠️ Enhanced rules for corrective actions, including Field Safety Corrective Actions (FSCA) 📊 Tighter investigation and reporting for serious incidents & trends 🗂️ New retention policies for manufacturer documentation These changes aim to improve safety, performance, and quality monitoring for medical devices throughout their lifecycle. If your devices are marketed in Great Britain, be sure to familiarise yourself with the new obligations. What are your thoughts on these proposed changes?? #MedicalDevices #UKRegulations #MHRA #Healthcare #PostMarketSurveillance #MedTech
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📢 The MHRA has recently published a draft amendment to the medical device regulation in the UK, concerning the PMS. See the text here: https://lnkd.in/etFsFdKP This draft amendment includes: • Updates definitions that will apply for the purposes of post-market surveillance (PMS). • Contains new PMS requirements for devices and accessories that are placed on the market or put into service in Great Britain. • Manufacturers must establish a post-market surveillance system, which should be based on a PMS plan. • Outlines requirements for manufacturers to take preventive and corrective actions, includes field safety corrective actions (FSCA). • Imposes investigation and reporting requirements on manufacturers in relation to serious incidents and trends in incidents. • Provides for the retention of the documentation produced by a manufacturer. If you are working in the UK region and have any questions about what these updates mean, please reach out. We are happy to have a chat about how this amendment will affect your projects. #Qmed #MHRA #ClinicalAffairs #RegulatoryAffairs #MedicalDevices And thanks to our Regulatory Affairs Principal Advisor, Claudia Argenti for her help in preparing this content.
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Learn how Post-Market Surveillance (PMS) reports 📊 ensure medical device safety 🛡️ and performance ⚙️ through continuous monitoring 📈, analysis 🔍, and regulatory compliance 📋. Read the Full Article: https://lnkd.in/gPWdQc2n #MedicalDevices #PMSReports #SafetyFirst #HealthcareInnovation #DeviceMonitoring #RegulatoryCompliance #MedicalSafety #ContinuousImprovement #HealthcareQuality #PostMarketSurveillance 🚀 Elevate Your Medical Device Success with Our Expertise! Kickstart your PMS and PMCF requirements with Bioexcel, your trusted partner in medical device compliance. Our expert team ensures seamless and efficient processes to keep your devices compliant and safe. 📧 Connect with us today: bd@bioexcelife.com jaspalsingh@bioexcelife.com #Bioexcel #MedicalDeviceExperts #HealthcareInnovation #DigitalClinicalTrials #ClinicalResearch #Healthcare #DeviceSafety #MedicalDeviceResearch
PMS Reports: Ensuring Ongoing Device Safety
https://bioexcelife.com
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MEDIcept Minute: UK MHRA Post-Market Surveillance (PMS) Update Big news for medical devices in Great Britain! On December 20, The UK Government published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, introducing crucial updates to enhance PMS systems and manufacturer accountability. Key Highlights: - PMS plans now mandatory for manufacturers. - PMS Reports (PMSR) required for low-risk devices, updated every 3 years. - Periodic Safety Update Reports (PSURs) required for medium and high-risk devices, updated every 2 years (annually for high-risk). - Extended PMS documentation retention—10 years for most devices, 15 years for implantables. These regulations, coming into force in 6 months, mark a significant step in strengthening device safety and post-market oversight. Read more about this from MedBoard at the link below. https://lnkd.in/ef4GBZsV Need expert support to navigate these changes? Contact MEDIcept Inc. at sales@medicept.com. Let’s ensure your compliance and success in the evolving regulatory landscape. #MedTech #PostMarketSurveillance #UKRegulations #RegulatoryAffairs #MedicalDevices
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Emergo by UL reports on the UK MHRA and its penultimate draft “final draft” (22 October) for the Statutory Instrument on Post-Market Surveillance (PMS), PMS SI. This was first shared as a draft in July 2023 (July 26, 2023), and part of the MHRA’s January 2023 plan. Based on stakeholder responses to the July 2023 draft, the MHRA has now shared this final draft PMS SI. As part of the MHRA announcement, a statement from Laura Squire, MedTech Regulatory Reform Lead and Chief Officer, MHRA was shared. One quote: “While the new legislation is focused on patient safety, it also benefits innovation and growth of the sector, with the collection of real-world data helping manufacturers to further improve existing products.” It is possible this PMS SI would become law in the summer of 2025. Review our assessment of the PMS SI, with our program manager Karen Hill: https://lnkd.in/g9txWm2R . And, our recent regulatory update on PMS in the EU: https://lnkd.in/gBw_XfQA . #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #globalharmonization #medtech #medicaldevices #lifesciences #MHRA #PMS #medicaldevice #regulatory
MHRA Publishes Draft Post-Market Surveillance Requirements
emergobyul.com
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🚨 UK MHRA News: Important Updates on Post-market Surveillance (PMS) for Medical Devices 🚨 The UK MHRA has released a new draft Statutory Instrument: "The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024." This amendment to the Medical Devices Regulations 2002 (S.I. 2002/618) introduces significant changes that will affect manufacturers and their obligations around the ongoing monitoring of devices once placed on the market. Key updates include: • New definitions for Post-market Surveillance (PMS) • Stricter PMS requirements for devices and accessories sold or in use in Great Britain • Obligations for manufacturers to establish a PMS system based on a defined PMS plan • Detailed requirements for preventive/corrective actions, including Field Safety Corrective Actions (FSCA) • Investigation and reporting requirements for serious incidents and incident trends • Requirements for retention of documentation by manufacturers These new measures aim to strengthen oversight and ensure the safety, performance, and quality of medical devices over their lifecycle. Devices placed on the market post-enforcement will be subject to the updated regulations, while previous requirements will continue to apply for older devices. For more information on these updates, you can review the MHRA's draft below. 📢 If you would like to discuss how these changes might impact your operations, feel free to reach out to us at Apotech Consulting. We’re here to help you navigate these new regulatory requirements! Visit our website for more details: www.apotechconsulting.com #MedicalDevices #PostMarketSurveillance #MHRA #RegulatoryUpdates #PMS #MedicalRegulations #ApotechConsulting
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