UK MHRA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
MHRA Updates List of Medical Devices Granted Exceptional Use Authorisations, Including Cancellations
2026-07-10 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of manufacturers and medical devices that have received exceptional use authorisations, along with those whose exemptions have expired or been cancelled. Affected stakeholders include device manufacturers, importers, and healthcare providers who rely on such authorisations for continued market access. Organisations should review the list to confirm the current status of any devices they supply or use, and take immediate action if an authorisation has been revoked to ensure compliance.
Tags: mhra, exceptional_use_authorisation, medical_device_exemption, regulatory_decision, market_access
MHRA Updates Guidance on Registering Medical Devices for Great Britain and Northern Ireland Markets
2026-07-08 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has updated its guidance on how to register medical devices for the Great Britain and Northern Ireland markets. Manufacturers and authorised representatives must register their devices with the MHRA before placing them on the market, following class-specific routes and deadlines. The guidance addresses both UKCA and CE marking requirements for Northern Ireland.
Tags: medical_device_registration, mhra_guidance, uk_market_access, regulatory_update
MHRA Releases Compilation of Field Safety Notices for 29 June – 3 July 2026
2026-07-07 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published its weekly summary of Field Safety Notices (FSNs) issued by medical device manufacturers during 29 June to 3 July 2026. This list covers a range of devices and includes mandatory actions such as recalls, software updates, or device inspections. Healthcare providers, device users, and distributors should review the notices to identify affected products and implement the recommended safety measures immediately.
Tags: field_safety_notice, mhra, medical_device, recall, safety_alert, uk_regulation
MHRA Updates Guidance on Clinical Investigation Notifications for Medical Devices
2026-07-06 | UK MHRA | Regulation Update | !! MEDIUM
The UK's MHRA has published updated guidance outlining the process for notifying the regulator about planned clinical investigations for medical devices. Sponsors and manufacturers must submit specific notification forms with required documentation before starting a study in the UK. This update ensures clarity on regulatory obligations and patient safety requirements for all parties involved in medical device clinical investigations.
Tags: clinical_investigations, mhra, notification, medical_devices, uk_regulations, guidance_update
Borderline products: MHRA guidance on determining if your product is a medicine
2026-07-02 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA guidance outlines the decision-making process for classifying products as medicinal products (medicines) versus medical devices or other categories. It covers essential criteria such as product presentation, pharmacological action, and intended purpose. Manufacturers of potentially borderline products should review this guide to ensure proper classification and comply with UK regulatory requirements, avoiding misclassification risks.
Tags: borderline_products, medicine_classification, mhra_guidance, product_classification, medical_device_regulation
UK MHRA Publishes Field Safety Notices for 22–26 June 2026
2026-06-30 | UK MHRA | Safety Communication | !! MEDIUM
This item lists 10 field safety notices (FSNs) issued by medical device manufacturers during the week of 22–26 June 2026, as compiled by the UK MHRA. It alerts healthcare professionals, patients, and regulatory affairs teams to potential safety issues and required corrective actions. Affected parties should immediately review the notices, identify relevant devices, and implement any field safety corrective actions. The compilation is part of the MHRA's routine safety communication.
Tags: field_safety_notice, mhra, medical_device_safety
MHRA Safety Roundup – June 2026: Latest Safety Advice for Medicines and Medical Devices
2026-06-30 | UK MHRA | Safety Communication | !! MEDIUM
This June 2026 roundup from the UK MHRA consolidates the latest safety updates for both medicines and medical devices. Healthcare professionals, patients, and device users should review the listed warnings, recalls, and guidance to ensure continued safe use. The document highlights key actions including checking affected products and reporting adverse incidents through the Yellow Card scheme. It serves as a monthly compliance resource for vigilance and risk management.
Tags: mhra, safety_roundup, medical_devices, medication_safety, post_market_surveillance
MHRA Field Safety Notices compilation for 22–26 June 2026: 6 new device alerts published
2026-06-30 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA released a weekly list of six Field Safety Notices issued between 22 and 26 June 2026. Healthcare professionals and medical device organisations should review the notices to identify any relevant safety actions, such as software updates, part replacements, or usage modifications, and implement manufacturer instructions promptly to maintain patient safety and regulatory compliance.
Tags: field_safety_notice, mhra, medical_device_safety, regulatory_alert, postmarket_surveillance
MHRA Issues Updated Guidance on Borderline Products: Medical Devices vs Other Products
2026-06-29 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published updated guidance on borderline products, explaining the principles used to decide whether a product is a medical device and whether the Medical Devices Regulations 2002 apply. The document provides examples, flowcharts, and case studies to help manufacturers determine if their product falls under medicines, cosmetics, food, or general product safety regulations instead. Stakeholders should use this guidance to ensure correct classification and regulatory compliance in the UK market.
Tags: borderline_products, medical_device_classification, mhra_guidance, uk_regulations
MHRA Guidance: Registering Medical Devices for the Great Britain and Northern Ireland Markets
2026-06-26 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance outlines the process for registering medical devices before they can be placed on the market in Great Britain and Northern Ireland. It applies to manufacturers, authorised representatives, and responsible persons, who must ensure all devices are properly registered under the UK Medical Devices Regulations 2002. Key steps include identifying the correct registration route, submitting required device information, and maintaining compliance with post-market obligations. Failure to register can result in enforcement action and prevent lawful sale.
Tags: medical_device_registration, mhra, market_access, uk_compliance
MHRA Field Safety Notices: 15-19 June 2026 – 10 New Notices Published
2026-06-23 | UK MHRA | Safety Communication | !! MEDIUM
This item aggregates 10 field safety notices issued by the UK MHRA between 15 and 19 June 2026. The notices cover various medical devices requiring corrective actions or safety communication from manufacturers. Healthcare providers and device manufacturers must review the list to identify affected products and implement any mandated actions to ensure patient safety and regulatory compliance.
Tags: field_safety_notices, mhra, medical_device_safety, post_market_surveillance, regulatory_compliance
UK MHRA Weekly Field Safety Notices Compilation: 15–19 June 2026
2026-06-23 | UK MHRA | Regulation Update | !! MEDIUM
This item lists all Field Safety Notices (FSNs) issued by the UK MHRA between 15 and 19 June 2026, covering post-market safety actions for medical devices and IVDs. It affects manufacturers, healthcare providers, and users who must review the notices for relevant corrective actions. Key actions include identifying affected devices in inventory, implementing manufacturer instructions, and reporting any incidents.
Tags: field_safety_notices, mhra, medical_device_safety
MHRA Decision: List of Medical Devices Granted Exceptional Use Authorisations
2026-06-23 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of manufacturers and medical devices that have been granted exceptional use authorisations. The list also includes devices whose exemptions have expired or been cancelled. Affected manufacturers, importers, and healthcare providers should review the list to verify the current status of relevant products and ensure continued compliance with the applicable conditions of the authorisation.
Tags: exceptional_use, mhra_authorisation, medical_devices, regulatory_update
MHRA Weekly Field Safety Notices: 8-12 June 2026
2026-06-15 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA published the compilation of Field Safety Notices (FSNs) issued between 8 and 12 June 2026. These notices alert healthcare professionals and users to safety issues with medical devices and medicinal products, requiring actions such as product checks, modifications, or recalls. Manufacturers and responsible persons should review the list to identify any notices relevant to their products and ensure compliance with required actions. This weekly update is part of MHRA’s routine safety surveillance.
Tags: uk_mhra, field_safety_notice, safety_surveillance
MHRA Field Safety Notices for 1–5 June 2026 Now Available
2026-06-08 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published the weekly list of Field Safety Notices (FSNs) for 1–5 June 2026. This compilation affects healthcare providers and organisations using affected medical devices in the UK. Users should review each notice and take recommended actions to address potential safety issues with specific devices.
Tags: field_safety_notice, mhra, medical_devices, uk_regulation, safety_alert