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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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