tag:www.gov.uk,2005:/government/organisations/medicines-and-healthcare-products-regulatory-agency Medicines and Healthcare products Regulatory Agency - Activity on GOV.UK HM Government 2025-06-16T10:16:24Z /government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain#2025-06-16T10:16:24Z 2025-06-16T10:16:24Z First major overhaul of medical device regulation comes into force across Great Britain New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market. /guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Field safety notices: guidance for manufacturers How to write clear and effective field safety notices (FSNs) for medical devices. /guidance/device-specific-vigilance-guidance-cardiac-implantable-electronic-devices-cieds#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Device specific vigilance guidance: Cardiac Implantable Electronic Devices (CIEDs) Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable. /guidance/device-specific-vigilance-guidance-artificial-heart-valves#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Device specific vigilance guidance: Artificial Heart Valves Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable. /government/publications/field-safety-notice-fsn-what-it-is-and-why-its-important#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Guidance: Field safety notice (FSN): what it is and why it's important A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action. /guidance/device-specific-vigilance-guidance-inferior-vena-cava-ivc-filters#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Device specific vigilance guidance: Inferior vena cava (IVC) filters Guidance for manufacturers of IVC filters. It outlines specific scenarios that should be considered when determining if an incident is reportable. /government/publications/medical-devices-post-market-surveillance-requirements#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Guidance: Medical devices: post-market surveillance requirements How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain. /government/publications/medical-devices-examples-of-reportable-incidents#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Guidance: Medical devices: examples of reportable incidents Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK. /government/publications/custom-made-medical-devices#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Guidance: Custom-made medical devices in Great Britain How to comply with the regulatory requirements for manufacturing custom-made medical devices. /government/publications/medical-devices-periodic-safety-update-report-psur#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Guidance: Medical devices: periodic safety update report Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR). /guidance/device-specific-vigilance-guidance-coronary-stents-and-associated-delivery-systems#2025-06-16T09:00:01Z 2025-06-16T09:00:01Z Device specific vigilance guidance: Coronary Stents and associated delivery systems Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable. /government/publications/mhra-performance-data#2025-06-16T08:33:06Z 2025-06-16T08:33:06Z Transparency data: MHRA Performance Data Performance data for MHRA key performance indicators (KPIs) and information on the expected timeline to complete a specific regulatory function. /drug-device-alerts/mhra-safety-roundup-may-2025#2025-06-13T14:11:47Z 2025-06-13T14:11:47Z MHRA Safety Roundup: May 2025 Summary of the latest safety advice for medicines and medical device users /government/publications/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know#2025-06-12T15:30:49Z 2025-06-12T15:30:49Z Guidance: GLP-1 medicines for weight loss and diabetes: what you need to know Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes. /drug-device-alerts/class-2-medicines-recall-inhixa-12000iu-120mg-slash-0-dot-8ml-solution-for-injection-maxearn-limited-el-25-a-slash-27#2025-06-12T13:40:15Z 2025-06-12T13:40:15Z Class 2 Medicines Recall: Inhixa 12,000IU (120mg)/0.8mL solution for injection, Maxearn Limited, EL(25)A/27 Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton. /government/publications/medicines-that-cannot-be-parallel-exported-from-the-uk#2025-06-10T16:08:52Z 2025-06-10T16:08:52Z Guidance: Medicines that you cannot export from the UK or hoard Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients. /guidance/decentralised-manufacture-the-designation-step#2025-06-10T12:57:24Z 2025-06-10T12:57:24Z Decentralised manufacture: »Ê¹ÚÌåÓýapp designation step MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture. /guidance/decentralised-manufacture-marketing-authorisation-application#2025-06-10T12:57:21Z 2025-06-10T12:57:21Z Decentralised Manufacture: Marketing Authorisation application Guidance on applying for a Marketing Authorisation for Decentralised Manufacture, including eligibility, process, and requirements. /guidance/decentralised-manufacture-uk-guideline-of-good-pharmacovigilance-practices#2025-06-10T12:57:17Z 2025-06-10T12:57:17Z Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)). /guidance/decentralised-manufacture-labelling#2025-06-10T12:57:14Z 2025-06-10T12:57:14Z Decentralised Manufacture: Labelling Guidance on labelling requirements pertinent to the type of medicinal product and its supply status, as defined in UK legislation.