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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 

📢 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.

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

New MDCG Guidance on Surveillance for Legacy Devices The Medical Device Coordination Group (MDCG) has released the revised guidance document (MDCG 2022-4 Rev. 2) on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR. 🔍 Key Highlights: 1) Transitional Provisions: Devices with valid certificates under MDD or AIMDD can remain on the market until December 2027 or 2028, depending on their classification, if they meet specific conditions. 2) Surveillance Responsibilities: Notified bodies that issued the original certificates under MDD or AIMDD are responsible for continued surveillance until September 2024. Post this date, MDR-designated notified bodies will take over. 3) Quality Management Systems: Manufacturers must align their QMS with MDR requirements by May 26, 2024, focusing on post-market surveillance, market vigilance, and registration of economic operators and devices. 4) Periodic Safety Update Reports (PSURs): These must be prepared and made available to competent authorities, ensuring ongoing safety and performance monitoring. 💡 Stay informed and prepared to maintain compliance and ensure patient safety. #MedicalDevices #MDR #Compliance #RegulationUpdate #ClinicalEvaluation

🚨 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

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

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

🔍 𝗔𝘁𝘁𝗲𝗻𝘁𝗶𝗼𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀! 🔍 The Dutch Health and Youth Inspectorate (IGJ) has just released an important report urging manufacturers of medical devices to pay greater attention to Post-Market Surveillance (PMS). You can read the report here: https://lnkd.in/epEyMVzA Recent inspections have revealed that many manufacturers are not prioritizing PMS adequately, which can have serious consequences for user safety and the performance of medical devices. The IGJ emphasizes the need for manufacturers to integrate PMS into their quality management systems and clearly assign responsibility within their organizations. As the IGJ continues to monitor compliance with PMS requirements, it’s crucial for manufacturers to take action now. At Certification Experts, we specialize in helping manufacturers establish effective PMS systems that not only meet regulatory requirements but also enhance product safety and quality. Let’s work together to ensure the highest standards in medical device safety! #MedicalDevices #PostMarketSurveillance #QualityManagement #CertificationExperts #SafetyFirst

📢 Strengthening Medical Device Safety with Improved Field Safety Notices (FSNs) The European Medical Device Regulation (MDR) 2017/745 mandates consistent reporting of serious incidents and corrective actions by device manufacturers. Before MDR, FSNs varied widely in format and content across countries, complicating trend analysis in PMS. A recent study conducted as part of the CORE-MD project, funded by the European Union’s Horizon 2020 program, has highlighted significant variations in the quality of Field Safety Notices (FSNs) for medical devices across different countries. However, inconsistencies in FSN formats and reporting standards make it challenging to conduct reliable trend analysis. Out of 126 405 FSNs analysed, Italy led with 31% of its FSNs classified as "Excellent." Other countries were grouped into high, moderate, and low-quality clusters, with nations like the USA, Netherlands, and Sweden producing higher-quality notices, while others lagged. Contrary to expectations, no significant difference was found between EU and non-EU countries in FSN quality, despite the stricter regulatory framework in the EU. The study found three distinct clusters of FSN quality, revealing a fragmented landscape that complicates post-market surveillance. 🌍 A global minimum reporting standard is essential to unlock the full potential of FSN data in safeguarding health worldwide. Link to CORE-MD Post-Market Surveillance Tool: https://lnkd.in/duzAayyM #MedicalDevices #HealthSafety #DigitalHealth #PublicHealth #MedicalRegulations #COREMD #Horizon2020 #Vigilance #MDR #PMS #Surveillance #Quality #RegulatoryAffairs #EU #Safety #HealthcareInnovation #PatientSafety #Cardiovascular

📢 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. #intelligence #notifiedbody #notifiedbodies #audit #medicaldevices #ivdr #mdr #medicaldevice #medicaldevices #surveillance #automation #regulatoryintelligence #clinicalinvestigations #pms #mhra