Regulatory Changelog
Latest digital health & SaMD compliance updates — auto-generated daily.
- Low
Research: National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework
Source: mhra
- The National Commission into the Regulation of AI in Healthcare has published recommendations to advise government on a future regulatory framework for AI in healthcare.
- The supplied text describes the material as research and recommendations, indicating proposals for consideration rather than binding regulatory requirements.
- No effective date, obligations, or technical requirements are stated in the supplied summary; the original source must be reviewed before compliance decisions.
- Low
Pre-submission Advice & Support for Innovative Medicines
Source: mhra
- MHRA offers a pre-submission service for innovative medicines.
- Service is described as available before applying for medicines Marketing Authorisations.
- Service is described in relation to clinical variations for innovative medicines.
- Low
Opportunities for patients and the public to be involved in the work of the MHRA
Source: mhra
- Source describes opportunities for patients and the public to be involved in the work of the MHRA.
- Scope is described as engagement and involvement in MHRA regulatory decision-making.
- Supplied summary states no binding requirements, dates, or SaMD-specific technical details; original source must be reviewed for full context.
- Low
Notice: Register of brokers authorised to deal in human medicines
Source: mhra
- Notice provides a current listing of UK brokers authorised to broker human medicines.
- Listing includes company name, registration and address information.
- No new obligations, proposals, or technical requirements are stated in the supplied summary; it is described as an informational register.
- Low
Notice: Medicines: terminated and cancelled manufacturing and wholesale dealer licences
Source: mhra
- Notice identifies UK companies with terminated and cancelled licences
- Covers licences to manufacture medicines
- Covers licences to wholesale medicines
- High
National Patient Safety Alert: Patient hoists and slings (all types): risk of death and serious harm from falls (NatPSA/2026/005/MHRA)
Source: mhra
- Alert covers patient hoists and slings (all types) for risk of death and serious harm from falls.
- Fatal and serious harm continues to occur when patients fall during transfers and repositioning.
- Review of recent fatal incidents and wider surveillance data shows an average of two deaths per year since 2015.
- Low
National assessment procedure for medicines
Source: mhra
- MHRA source titled National assessment procedure for medicines.
- Described as guidance on the MHRA's national assessment procedure for marketing authorisation applications.
- Supplied summary contains no effective date, binding requirements, or SaMD-specific details.
- Medium
MHRA sets out steps to prevent avoidable harm from patient hoists
Source: mhra
- A National Patient Safety Alert has been issued related to patient hoists
- The alert sets out practical steps described as recommendations to reduce the risk of harm during use
- The supplied summary identifies improved checks and maintenance as the focus, with no binding requirements or effective date stated
- Low
MHRA and Malaysia strengthen partnership on healthcare innovation and research
Source: mhra
- MHRA has reaffirmed its commitment to strengthening regulatory collaboration with Malaysia
- High-level discussions took place in Kuala Lumpur focused on healthcare innovation and research
- Supplied summary states collaboration commitment only, with no binding requirements or technical details provided
- Low
Medicines: apply for a variation to your marketing authorisation
Source: mhra
- Source describes applying for changes to a marketing authorisation.
- Source lists minor variations type IA and IB as in scope.
- Source lists major variations type II and extensions as in scope.
- Low
Independent Commission led by NHS doctors sets out blueprint to accelerate safe AI adoption in healthcare
Source: mhra
- Independent NHS doctor-led Commission has issued a blueprint with new recommendations for AI adoption in healthcare.
- Recommendations are based on extensive public engagement and describe how the NHS could provide faster patient access to AI advances.
- Recommendations propose proportionate safeguards to protect patient safety and maintain trust; text describes proposals only, not binding requirements.
- Low
Guidance: National Patient Safety Alert Supporting Information. Patient hoists and slings: incidents and case examples.
Source: mhra
- Supporting information to accompany the National Patient Safety Alert on patient hoists and slings NatPSA/2026/005/MHRA.
- Titled content focuses on incidents and case examples for patient hoists and slings.
- No effective date, binding requirements, or technical details stated in supplied summary; original source must be reviewed before compliance decisions.
- Low
Guidance: COVID-19 test validation approved products
Source: mhra
- This MHRA guidance relates to COVID-19 test validation approved products.
- Its stated purpose is to help users find out which COVID-19 test products have been approved.
- No binding requirements, dates, or technical details are provided in the supplied summary text.
- Low
Field Safety Notices: 7 September to 11 September 2026
Source: mhra
- MHRA published a list of Field Safety Notices covering 7 September to 11 September 2026.
- Supplied summary provides no device types, safety issues, manufacturers, or required actions.
- Original source must be reviewed before compliance decisions; binding versus informational status cannot be determined from summary alone.
- Low
Field Safety Notices: 31 August to 4 September 2026
Source: mhra
- MHRA published a list of Field Safety Notices covering 31 August to 4 September 2026.
- Supplied summary provides no details on affected devices, manufacturers, risks, or binding requirements.
- Original source must be reviewed before compliance decisions as this appears to be a feed summary only.
- Low
Decision: Medicines: new manufacturing and wholesale dealer licences
Source: mhra
- List of sites granted a manufacturer licence for medicines.
- List of sites granted a wholesale dealer licence for medicines.
- Source identified as MHRA decision publication.
- Low
Decision: Human and veterinary medicines: register of licensed manufacturing sites
Source: mhra
- Source is described as the MHRA register of licensed manufacturing sites.
- Register scope includes manufacturer specials - human (MS) only as stated in summary.
- Register scope includes manufacturer specials authorisation - veterinary (MANSA) only as stated in summary.
- Low
Decision: Advertising investigations: August 2026
Source: mhra
- MHRA published a decision update titled Advertising investigations: August 2026.
- Update concerns decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.
- Feed summary does not provide specific decisions, obligations, or technical details.
- Low
Corporate report: MHRA-NICE Real-World Evidence Scientific Dialogue
Source: mhra
- Described as MHRA-NICE Real-World Evidence Scientific Dialogue programme
- Stated to help decision making across the lifecycle of products
- Stated to benefit both regulatory and health technology assessment (HTA) evaluations
- Low
Clinical trials for medicines: Good clinical practice inspections
Source: mhra
- MHRA source titled 'Clinical trials for medicines: Good clinical practice inspections' was referenced.
- Supplied summary states the source contains information relating to good clinical practice (GCP) inspections.
- No binding requirements, detailed scope, or effective date were included in the supplied feed summary.