UK MHRA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
MHRA National Patient Safety Alert: ResMed Astral 100/150 Ventilators Unexpected Ventilation Interruption
2026-08-17 | UK MHRA | Safety Communication | !!! HIGH
This MHRA National Patient Safety Alert (NatPSA/2026/004/MHRA) concerns ResMed Astral 100 and 150 ventilators and associated Printed Circuit Board Assembly spare parts manufactured before October 2024. A device fault can cause unexpected interruption of ventilation therapy, potentially resulting in patient harm. Affected users, caregivers, and healthcare providers should identify affected devices and implement the actions specified in ResMed's Field Safety Notice and the MHRA alert.
Tags: mhra, resmed_astral, ventilator, field_safety_notice, patient_safety
MHRA Publishes Suspended and Revoked Licences for Medicines Manufacturers and Wholesalers
2026-08-17 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has updated its public list of companies whose licences or registrations to manufacture or wholesale medicines and active ingredients have been suspended or revoked. The list affects manufacturers, wholesalers, and trading partners in the UK medicines supply chain. Regulatory affairs and quality professionals should check the current list to verify the compliance status of suppliers, contract manufacturers, and distributors, and take immediate action if a partner appears on the list.
Tags: uk_mhra, medicine_licensing, enforcement
MHRA Updates List of Medical Devices Granted Exceptional Use Authorisations
2026-08-14 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA decision provides an updated list of manufacturers and medical devices that have been granted exceptional use authorisations (exemptions) in the UK. It also identifies devices whose exemptions have expired or been cancelled. Regulatory affairs professionals should review the list to confirm the current authorisation status of relevant devices and take action if a product's exemption is no longer active.
Tags: exceptional_use_authorisation, mhra, medical_device_exemption
MHRA Guidance: Notify Clinical Investigations for Medical Devices
2026-08-12 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance explains how sponsors must notify the MHRA of their intention to conduct a clinical investigation for a medical device in the UK. It applies to manufacturers, sponsors, and clinical research organisations planning device studies. Affected parties should review the notification requirements, prepare the necessary documentation, and submit the notification to MHRA before starting the investigation.
Tags: mhra, clinical_investigation, medical_devices, regulatory_guidance
MHRA Field Safety Notices: 3 to 7 August 2026
2026-08-11 | UK MHRA | Safety Communication | !! MEDIUM
This MHRA page lists Field Safety Notices (FSNs) issued for medical devices and drug-device products between 3 and 7 August 2026. The update includes two new entries in the feed. Healthcare providers, medical device manufacturers, and users should review the listed notices and take any recommended actions for affected devices. FSNs may include recalls, safety alerts, or instructions for use changes.
Tags: field_safety_notices, mhra, medical_device_safety
MHRA Safety Alert: Medical Devices Supplied Without UKCA/CE Markings Must Be Removed and Quarantined
2026-08-10 | UK MHRA | Safety Communication | !!! HIGH
The MHRA has identified a number of medical devices on the UK market that lack valid UKCA or CE conformity markings and the required certification, breaching the UK Medical Devices Regulations 2002. Healthcare providers, importers, and distributors must immediately remove these non-compliant devices from use, place them in quarantine, and ensure they are not further distributed. The alert warns that failure to act may result in enforcement action and reiterates the need to verify conformity documentation before supply.
Tags: uk_mhra, safety_alert, non_compliant_device
MHRA advises quarantine of medical devices supplied without appropriate conformity markings
2026-08-10 | UK MHRA | Regulation Update | !!! HIGH
The MHRA has issued an advisory for economic operators to quarantine medical devices found on the UK market that lack required conformity markings under UK MDR 2002 or EU MDR 2017/745. Such devices may not meet essential safety and performance standards, posing risks to patients and users. The agency urges immediate inspection of stock and supply chains, and reporting of non-compliant products to the MHRA.
Tags: mhra_advisory, conformity_marking, quarantine_notice
MHRA: Remove from use and quarantine devices lacking valid UKCA/CE conformity markings or certification (DSI/2026/007)
2026-08-10 | UK MHRA | Regulation Update | !!! HIGH
The MHRA has identified medical devices being supplied on the UK market without valid UKCA or CE conformity markings or proper certification, breaching UK MDR 2002 and EU MDR 2017/745. Healthcare providers and suppliers are required to immediately remove these non-compliant devices from use and place them in quarantine. The devices must not be used or supplied until compliance is verified, and all incidents should be reported to the MHRA.
Tags: ukca_marking, ce_marking, non_compliance, quarantine, mhra_alert, medical_device_regulation
Belzer UW® Cold Storage Solution and Belzer MPS® (UW Machine Perfusion Solution): manufactured by Carnamedica (UKRP: Bri
2026-08-06 | UK MHRA | Safety Communication | !! MEDIUM
The MHRA is providing an update on defects previously identified with Belzer solutions for the preservation of donated organs. This DSI replaces advice in DSI/2023/005.
MHRA Guidance: Compiling a Submission for Clinical Investigations of Medical Devices
2026-08-06 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has released guidance detailing how sponsors should compile and submit notifications for clinical investigations of medical devices. It outlines the required documentation, format, and procedure, enabling manufacturers and sponsors to prepare complete applications and avoid delays. This guidance is crucial for anyone planning a clinical study in the UK.
Tags: clinical_investigation, mhra_guidance, submission_process
MHRA Field Safety Notices: 27 to 31 July 2026 (4 New Notices Published)
2026-08-04 | UK MHRA | Safety Communication | ! LOW
This item lists four field safety notices (FSNs) issued by the UK MHRA between 27 and 31 July 2026. These notices alert healthcare professionals and users to potential safety issues with specific medical devices. Affected parties should review the individual FSNs for details on affected products, risks, and recommended actions. The compilation serves as a weekly roundup for regulatory surveillance.
Tags: field_safety_notice, mhra, medical_device_safety, weekly_summary
Dräger Issues Expanded Field Safety Notice for Atlan Anaesthesia Workstations Ventilator Failure Risk (DSI/2026/005)
2026-08-04 | UK MHRA | Safety Communication | !!! HIGH
In April 2026, Dräger issued a follow-up Field Safety Notice expanding the number of affected Atlan Anaesthesia workstation devices due to a manufacturing defect that may cause mechanical ventilation failure. The MHRA safety alert (DSI/2026/005) advises healthcare providers to immediately identify and quarantine impacted devices, contact Dräger for corrective action, and review previous ventilation failure reports. This update follows an earlier notice and underscores the serious risk of unexpected ventilator shutdown during anaesthesia procedures.
Tags: drager, atlan_anaesthesia_workstation, ventilator_failure
UK MHRA Updates Public List of Suspended/Revoked Manufacturer and Wholesaler Licences (5 New Decisions)
2026-08-04 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has added five new decisions to its public enforcement list of suspended or revoked licences and registrations for manufacturers and wholesalers of medicines and active pharmaceutical ingredients. The list identifies entities no longer authorised to carry out these activities. Regulatory professionals should review the updated list to verify the compliance status of suppliers and partners, and take appropriate supply chain actions.
Tags: uk_mhra, license_suspensions, manufacturing_license, wholesale_license, enforcement, supply_chain_compliance
MHRA Field Safety Notices Summary: 27-31 July 2026
2026-08-04 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published a roundup of 5 new field safety notices (FSNs) issued between 27 and 31 July 2026, covering medical devices and drug-device combinations. This weekly list alerts healthcare professionals, device suppliers, and users to potential safety issues requiring immediate review. Recipients should identify affected products and follow the specified corrective actions to ensure patient safety and regulatory compliance.
Tags: field_safety_notices, mhra, medical_device_safety, recall_alert, regulatory_compliance
MHRA Updates List of Medical Devices Given Exceptional Use Authorisations
2026-07-31 | UK MHRA | Regulation Update | !! MEDIUM
The UK’s MHRA has published its latest decision listing medical devices that have been granted exceptional use authorisations. This exemption permits non-compliant devices to be used in specific clinical situations. The document includes manufacturer names, device details, and current statuses (active, expired, or cancelled). Stakeholders should review the list to verify the status of any devices they supply or use, ensuring continued compliance and patient safety.
Tags: exceptional_use_authorisation, mhra, medical_device_exemption, uk_regulations, list_update
MHRA July 2026 Safety Roundup: Latest Medicines and Medical Device Safety Advice
2026-07-30 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA published its monthly Safety Roundup for July 2026, highlighting two new safety advisory entries for medicines and medical device users. Healthcare professionals, patients, and device operators should review the roundup to stay updated on emerging risks and recommended actions. The document consolidates recent Drug Safety Update and Medical Device Alerts, serving as a routine information bulletin for the regulated community.
Tags: mhra, safety_roundup, drug_safety, medical_device_alert, compliance_update
MHRA Summer Advisory: Keep Medical Devices Safe in Hot Weather, Simple Precautions Urged
2026-07-29 | UK MHRA | Regulation Update | !! MEDIUM
The UK's MHRA has issued a seasonal reminder for patients and caregivers to take extra care with medical devices during hot weather. High temperatures can affect device performance, battery life, and the integrity of temperature-sensitive items like insulin pumps and glucose monitors. The agency advises keeping devices out of direct sunlight, storing them in cool places, and checking manufacturer instructions for safe operating temperature ranges.
Tags: summer_heat_safety, medical_device_care, mhra_advisory
MHRA Published 4 Field Safety Notices for 29 June to 3 July 2026
2026-07-29 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has released a list of 4 Field Safety Notices (FSNs) for the week of 29 June to 3 July 2026. These notices, issued by medical device manufacturers, highlight safety issues that may require corrective actions by healthcare providers or users. Affected organizations should promptly review each notice and implement any recommended measures to ensure patient safety and device compliance.
Tags: field_safety_notice, mhra, medical_device, recall, post_market_surveillance
MHRA Releases Field Safety Notices for 20–24 July 2026
2026-07-28 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA published its weekly compilation of Field Safety Notices (FSNs) for 20–24 July 2026, covering new alerts for medical devices. These notices inform healthcare providers, users, and manufacturers about identified safety issues and required corrective actions. Affected parties should immediately review the listed notices and implement any mandated field safety corrective actions to ensure continued compliance and patient safety.
Tags: field_safety_notice, mhra, safety_alert
MHRA Field Safety Notices: 20–24 July 2026 Weekly Summary
2026-07-28 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA published a list of field safety notices issued between 20 and 24 July 2026. These notices alert healthcare providers and manufacturers to medical device safety issues requiring corrective action. Affected parties should promptly review the notices and implement recommended measures to maintain patient safety.
Tags: field_safety_notices, mhra, medical_device_safety, weekly_update
MHRA Updates List of Medical Devices with Exceptional Use Authorisations
2026-07-24 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of medical devices and manufacturers granted exceptional use authorisations, allowing market access under specific exemptions. The list covers active authorisations as well as those expired or cancelled. Affected manufacturers, importers, and healthcare providers should review the list to verify the status of devices they supply or use, and take corrective actions if authorisations have lapsed. Regular monitoring of this list is essential for ongoing compliance and patient safety.
Tags: exceptional_use, mhra, medical_device_list, exemption, compliance
MHRA Guidance: Compiling a Submission for Clinical Investigations of Medical Devices
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has issued guidance for sponsors and manufacturers on how to compile a submission to notify them of a clinical investigation of a medical device. It details the required documents, format, and submission process to help ensure regulatory compliance. This guidance is essential for anyone planning a medical device clinical trial in the UK.
Tags: clinical_investigations, mhra_guidance, submission_process
MHRA Guidance: Determining if Your Medical Device Needs a Clinical Investigation in the UK
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance outlines the criteria for determining whether a medical device must undergo a clinical investigation under UK regulations, or if it qualifies for an exemption. It is aimed at manufacturers and sponsors placing devices on the Great Britain market, providing a step-by-step approach to assess clinical evidence requirements. The document clarifies regulatory expectations to support compliance and streamline the conformity assessment process.
Tags: clinical_investigation, mhra_guidance, medical_devices, uk_regulations, exemption_criteria
UK MHRA Guidance: How to Notify Clinical Investigations for Medical Devices
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
This updated MHRA guidance explains the process for sponsors to notify the UK regulator of their intent to conduct a clinical investigation of a medical device. It outlines required documentation, submission steps, and the regulatory pathway under UK legislation. Manufacturers and investigators must follow this guidance to ensure compliance before starting any clinical study involving devices.
Tags: clinical_investigation, mhra_notification, medical_devices, premarket_requirements, uk_regulations
MHRA Guidance on Conducting Clinical Investigations for Medical Devices in Great Britain
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance details how medical device manufacturers must plan, conduct, and report clinical investigations in Great Britain to comply with the Medical Devices Regulations 2002. It covers regulatory requirements, including the need for MHRA approval, ethical review, and notification of adverse events. Manufacturers and sponsors should use this document to ensure full compliance before initiating any clinical investigation in the GB market.
Tags: clinical_investigations, mhra_guidance, medical_devices, uk_regulations, compliance
MHRA Guidance on Approving Clinical Investigations for Medical Devices
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
This guidance outlines how the MHRA decides whether to approve a clinical investigation for medical devices. It is relevant to sponsors and manufacturers planning clinical trials in the UK, detailing the required information and assessment criteria. Key actions include understanding submission requirements, ensuring study designs meet safety and performance standards, and providing robust evidence for approval. The document updates existing guidance to align with current regulatory expectations.
Tags: clinical_investigations, mhra_guidance, medical_devices, approval_process, uk_regulations
MHRA Field Safety Notices Published 13–17 July 2026
2026-07-21 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published a list of Field Safety Notices (FSNs) issued between 13 and 17 July 2026. These notices alert healthcare professionals, patients, and device manufacturers to specific safety issues with medical devices. Recipients should review the list to identify any affected devices in their care or on the market and take the corrective actions detailed in each notice.
Tags: field_safety_notice, mhra, medical_devices, safety_alert, uk
MHRA Updates Public List of Suspended and Revoked Licences for Medicine Manufacturers and Wholesalers, Adding 8 New Entries
2026-07-21 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published an updated decision list of companies whose licences or registrations to manufacture or wholesale medicines and active pharmaceutical ingredients have been suspended or revoked. The update adds 8 new entries to the existing public register. Affected entities include manufacturers and wholesalers who have failed to meet regulatory standards. Industry stakeholders should review the list to assess any potential impact on their supply chains or business partners.
Tags: uk_mhra, licence_suspension, medicines_manufacturing, regulatory_enforcement, supply_chain_compliance
MHRA Weekly Field Safety Notices Roundup: 13-17 July 2026
2026-07-21 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA publication lists 8 Field Safety Notices (FSNs) issued for medical devices during the week of 13 to 17 July 2026. Healthcare professionals and organizations should review the notices to identify affected devices in their inventory and follow the manufacturer-recommended actions. The notices cover various device categories and safety issues.
Tags: field_safety_notice, mhra, weekly_listing, medical_devices, post_market_surveillance
MHRA Guidance: Register Medical Devices to Place on the Market in Great Britain and Northern Ireland
2026-07-20 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has issued updated guidance on the mandatory registration of medical devices before they can be placed on the Great Britain and Northern Ireland markets. It applies to manufacturers, authorised representatives, and importers, detailing the registration process, use of the Public Access Registration Database (PARD), and alignment with the UK Medical Devices Regulations 2002. The guidance covers initial registration, updates, and compliance timelines, emphasising that no device can be marketed without valid MHRA registration.
Tags: medical_device_registration, mhra, uk_market_access, pard, compliance
MHRA Issues Guidance on Legal Requirements for Prosthetic, Orthotic and Ophthalmic Devices
2026-07-20 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published new guidance detailing the specific regulations that apply to manufacturers of prosthetic, orthotic and ophthalmic medical devices. The document clarifies obligations for conformity assessment, registration and post-market surveillance under the UK Medical Devices Regulations. Manufacturers of these specialized devices should review the guidance to ensure full compliance and avoid regulatory gaps. This update continues MHRA’s effort to offer sector-specific regulatory clarity.
Tags: mhra_guidance, prosthetics_orthotics_ophthalmics, legal_requirements
MHRA Issues Guidance on Compliance for Custom-Made Medical Devices in Great Britain
2026-07-20 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance outlines the regulatory requirements for manufacturing custom-made medical devices in Great Britain under the UK Medical Devices Regulations 2002. It explains who qualifies as a manufacturer of custom-made devices, what documentation and quality system obligations apply, and how to demonstrate conformity. Manufacturers must review these expectations to ensure they meet legal duties and maintain market access.
Tags: custom_made_devices, uk_mhra, regulatory_guidance, medical_device_compliance
MHRA Updates List of Medical Devices with Exceptional Use Authorisations (Including Expired/Cancelled Exemptions)
2026-07-17 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of manufacturers and medical devices granted exceptional use authorisations (exemptions), as well as those whose authorisations have expired or been cancelled. This transparency document allows stakeholders to verify which devices may be lawfully placed on the UK market under special conditions. Affected manufacturers should review the list to confirm their product’s status and ensure compliance with any conditions attached. Regulatory professionals should monitor the list for changes that may impact market access.
Tags: exceptional_use_authorisation, mhra, medical_devices, exemption_list, uk_regulation
UK MHRA Updates Guidance: List of Approved Bodies for Medical Device Conformity Assessments
2026-07-17 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has released updated guidance listing the organisations currently approved to conduct conformity assessments on medical devices. Manufacturers and authorised representatives must consult this list to identify valid Approved Bodies for UKCA or CE marking purposes. The document details each body’s designation scope, enabling stakeholders to verify which bodies can assess specific device categories. Staying informed about the latest approved bodies is critical for maintaining compliance and market access in Great Britain.
Tags: uk_mhra, approved_bodies, conformity_assessment, medical_devices, guidance_update
MHRA Field Safety Notices Summary: 6–10 July 2026
2026-07-14 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published its weekly list of Field Safety Notices (FSNs) for the period 6 to 10 July 2026. This compilation contains safety alerts and corrective actions for medical devices and in-vitro diagnostics distributed in the UK. Affected healthcare providers and users should review the specific notices for device models and implement recommended actions without delay. Regulatory affairs professionals are advised to monitor these notices for potential impacts on their product portfolios.
Tags: field_safety_notices, mhra, medical_device_safety
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