UK Safety Communications for Medicines, Medical Devices, and Healthcare Products

1. Purpose

The Medicines and Healthcare products Regulatory Agency (MHRA) monitors the safety of medicines and medical devices available to UK patients, balancing their benefits and risks. No medical product is completely free of risk, so the MHRA communicates transparently when new safety issues are identified to minimise risks or remove products from use. Patient safety is the highest priority, and safety communications are issued to protect the public. These communications are shared via the MHRA website, media, social media, and notifications. Healthcare professionals and the public can sign up for updates. All healthcare professionals are responsible for using safety information in treating and caring for patients. https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products Safety communications can be found on GOV.UK, with an infographic providing a step-by-step guide (available at https://assets.publishing.service.gov.uk/media/67ecf1ace9c76fa33048c611/Safety_Communications_Infographic.pdf or printable version at https://assets.publishing.service.gov.uk/media/67ecf1c0e9c76fa33048c612/Safety_Communications_Infographic_-_Printable.pdf). Links to specific communications are provided in relevant sections. https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products

2. Types of Communications

The MHRA issues several types of safety communications, including:

• National Patient Safety Alerts (NHSAs): Used for safety-critical issues with a risk of death or disability from inaction. They target senior leaders in health and social care organisations in England, require clear actions with deadlines and senior oversight, and are assessed for feasibility, unintended consequences, equalities impact, effectiveness, and cost-effectiveness. Issued by accredited organisations like the MHRA via the Central Alerting System (CAS) in England, with consultation across UK devolved administrations. Searchable on the CAS website (https://www.cas.mhra.gov.uk/Home.aspx) or MHRA-specific alerts (https://www.gov.uk/drug-device-alerts?alert_type%5B%5D=national-patient-safety). Subscribe to notifications (https://www.gov.uk/drug-device-alerts/email-signup?alert_type%5B%5D=national-patient-safety). Guidance on management is available (https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103228). https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products
• Drug Safety Updates (DSUs): Communicate safety messages to support safer use of medicines and healthcare products. Targeted at UK healthcare professionals and those in management roles. Issued when action is needed to change clinical practice (e.g., prescribing, administering, dispensing, or patient advice) or to raise awareness on topics like new guidance. Published on the MHRA website and Yellow Card app, sent to professionals, guidance producers, and bodies, and collated in monthly safety roundups. Search existing DSUs (https://www.gov.uk/drug-safety-update). Subscribe to notifications (https://public.govdelivery.com/accounts/UKMHRA/subscriber/new?topic_id=UKMHRA_0044). https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products
• Medical Device Safety Bulletins (MDSBs): Referred to as Device Safety Information alerts, these communicate safety messages for medical devices. Issued when action is needed by providers, professionals, or patients to mitigate risks in use, availability, or effectiveness. May provide tailored advice for specific groups. Targeted at professionals, providers, distributors, users, and management roles. Often supplements manufacturer Field Safety Notices (FSNs) on corrective actions. Published on the MHRA website, issued to subscribers and cascaded via employers or bodies, collated in monthly roundups. Search existing alerts (https://www.gov.uk/drug-device-alerts?alert_type%5B%5D=device-safety-information). Subscribe to notifications (https://www.gov.uk/drug-device-alerts/email-signup). https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products
• Recalls or Notifications (Medicines): Used for defective medicinal products not complying with marketing authorisation or Good Manufacturing Practice. Alert professionals to defects and required actions. Issued by the Defective Medicines Report Centre (DMRC) in collaboration with marketing authorisation holders or distributors. Targeted at pharmacists, pharmacy workers, dispensing doctors, and others as needed. Published on the MHRA website, issued to subscribers and cascaded. DMRC minimises hazards by assessing and communicating between stakeholders. Manufacturers must report defects; recalls are decided with DMRC input. Categorised as:
  • Class 1: Immediate action (risk of death/disability; often with NHSA).
  • Class 2: Action within 48 hours (harm but not life-threatening).
  • Class 3: Action within 5 days (unlikely harm, e.g., non-compliance).
  • Class 4: Caution in use (minor defects, e.g., packaging errors).
  • Company-led: For targeted recalls without broad alerts. Search existing (https://www.gov.uk/drug-device-alerts?alert_type%5B%5D=medicines-recall-notification). Subscribe (https://www.gov.uk/drug-device-alerts/email-signup?alert_type%5B%5D=medicines-recall-notification). Guidance (https://www.gov.uk/government/publications/a-guide-to-defective-medicinal-products or PDF at https://assets.publishing.service.gov.uk/media/6103ba7a8fa8f5042c338d1c/DMRC_Guide-to-Defective-Medicinal_Products-Aug2021.pdf). https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products
• Safety Roundup Bulletin: Monthly summary of all safety alerts, including DSUs, Device Safety Information, NHSAs, recalls/notifications, and Direct Healthcare Professional Communications (DHPCs). Includes links to full alerts, QR codes for access, and news updates on MHRA safety projects. Introduced March 2025; prior summaries were on the Drug Safety Update page. Search existing (https://www.gov.uk/drug-device-alerts?alert_type%5B%5D=mhra-safety-round-up). Subscribe (https://subscriptions.mhra.gov.uk/accounts/UKMHRA/signup/45372). https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products
• Communications from Marketing Authorisation Holders and Manufacturers:
  • Direct Healthcare Professional Communications (DHPCs): Issued by marketing authorisation holders (not MHRA), reviewed and agreed by MHRA. Inform professionals of safety information on medicines. Targeted at prescribers/dispensers, clear and accessible. Examples: suspensions/withdrawals, indication restrictions, dose changes, supply issues, new warnings, risk data, effectiveness changes, adverse reaction advice. Published on MHRA website, collated in roundups. Guidance for holders (https://www.gov.uk/government/publications/how-to-draft-a-direct-healthcare-professional-communication). Search in roundups (https://www.gov.uk/drug-device-alerts?alert_type%5B%5D=mhra-safety-round-up) or prior DSUs (https://www.gov.uk/drug-safety-update). https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products
  • Field Safety Notices (FSNs): Issued by device manufacturers (not MHRA), notify customers of safety issues and corrective actions (FSCAs). Must notify MHRA beforehand unless urgent. Examples: withdrawals, use changes, warnings, instructions updates, risk data, effectiveness issues, labelling errors, software fixes. Published on MHRA website. Supplemented by Device Safety Information if needed. Search existing (https://www.gov.uk/drug-device-alerts?alert_type%5B%5D=field-safety-notices). Subscribe (https://www.gov.uk/drug-device-alerts/email-signup). Guidance for manufacturers (https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices). https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products

3. How They Are Issued

Safety communications are issued based on monitoring and review processes. The MHRA detects issues via data sources: spontaneous reporting (e.g., Yellow Card scheme at https://yellowcard.mhra.gov.uk/), studies, literature, devolved administrations, networks (MSO/MDSO), holders/manufacturers, regulatory authorities, and databases. Reviews involve gathering evidence, assessing strength, relevance, incidence, exposure, and mitigation. Internal experts review, with input from stakeholders, patients, or groups like the Commission on Human Medicines (https://www.gov.uk/government/organisations/commission-on-human-medicines) or Interim Device Working Group (https://www.gov.uk/government/groups/interim-devices-working-group) for public health impacts or concerns. Actions may include updating product information (e.g., Instructions for Use for devices, Patient Information Leaflets/Summary of Product Characteristics for medicines), risk minimisation, recalls, or withdrawals. Decisions on communications consider impacts, audience, and alternatives (e.g., social media). Types are chosen based on appropriateness, with timelines and accompaniments discussed. https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products

4. Related Links and Additional Information

• Yellow Card scheme: For reporting safety concerns (https://yellowcard.mhra.gov.uk/ or https://yellowcard.mhra.gov.uk/information).
• Pharmacovigilance guidance for holders (medicines): https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures/guidance-on-pharmacovigilance-procedures.
• Vigilance guidance for device manufacturers: https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance.
• Safety Public Assessment Reports: https://www.gov.uk/guidance/safety-public-assessment-reports.
• General search for alerts: https://www.gov.uk/drug-device-alerts.
• Email signup for various alerts: https://www.gov.uk/drug-device-alerts/email-signup. https://www.gov.uk/government/publications/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products/safety-communications-concerning-medicines-medical-devices-and-other-healthcare-products