UK MHRA Medicines
Material regulatory developments from Medicines & Healthcare products Regulatory Agency are tracked daily by Cresthaven Analytics. Over the last 90 days, 20 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
A selection of recent published briefs; this is not a complete archive.
MHRA secures suspended prison sentence and director disqualification after decade-long falsely certified medical device fraud investigation
The MHRA's Devices Compliance Unit secured a fraud conviction on September 23, 2026 at Manchester Crown Court, resulting in a three-year suspended sentence and an eight-year director disqualification for Kenneth George H…
Read the full UK MHRA Medicines brief →MHRA grants marketing authorisation for lurbinectedin as maintenance therapy in extensive-stage small cell lung cancer
The MHRA approved lurbinectedin (Zepzelca) on 23 September 2026 for adults with extensive-stage small cell lung cancer as maintenance therapy combined with atezolizumab. Pharma Mar, S.A. received the authorisation via th…
Read the full UK MHRA Medicines brief →MHRA issues Class 4 defect notification for B. Braun Meropenem 1000 mg over PIL errors in affected batches
The MHRA published a Class 4 Medicines Defect Notification on September 23, 2026, after B. Braun Melsungen AG self-reported errors in the Patient Information Leaflet included in certain batches of Meropenem 1000 mg powde…
Read the full UK MHRA Medicines brief →MHRA publishes eleven Field Safety Notices across cardiac, imaging, and diagnostic device categories for the week of 14 to 18 September 2026
The MHRA published eleven Field Safety Notices between 14 and 18 September 2026, covering devices from Abbott, Abiomed, bioMérieux, Biomet, Cook, GE Healthcare, Hologic, Intelerad, Percussionaire, Philips, and Serosep. T…
Read the full UK MHRA Medicines brief →MHRA publishes updated register of marketing authorisations granted in 2026
The MHRA published its running register of marketing authorisations granted in 2026 on September 18, 2026. This release is a periodic administrative update to the UK public record of approved medicines.
Read the full UK MHRA Medicines brief →MHRA issues device safety information on RF interference risks in wireless cardiotocography monitoring systems
The MHRA published Device Safety Information DSI/2026/012 on September 17, 2026, addressing patient safety risks in wireless cardiotocography systems that use radiofrequency telemetry channels. A review of these systems …
Read the full UK MHRA Medicines brief →MHRA issues Class 4 defect notification for Martindale clobazam oral suspension over linear barcode misprint across three batches
The MHRA's Defective Medicines Report Centre issued a Class 4 Medicines Defect Notification on September 17, 2026 covering three batches of Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150 mL. The …
Read the full UK MHRA Medicines brief →UK MHRA Medicines release pending Cresthaven Analytics full analysis: National Patient Safety Alert: Patient hoists and slings (all types): risk of death and serious harm from falls (NatPSA/2026/005/MHRA)
UK MHRA Medicines published a regulatory release titled 'National Patient Safety Alert: Patient hoists and slings (all types): risk of death and serious harm from falls (NatPSA/2026/005/MHRA)'. Cresthaven Analytics' full…
Read the full UK MHRA Medicines brief →MHRA issues National Patient Safety Alert on patient hoists and slings citing 22 fatal incidents since 2015
The MHRA published supporting information on 16 September 2026 for National Patient Safety Alert NatPSA/2026/005/MHRA, covering patient hoists and slings. The alert documents 22 fatal outcomes from hoist incidents report…
Read the full UK MHRA Medicines brief →MHRA publishes six Field Safety Notices across orthopaedic implants, cardiac devices, diagnostics, and imaging systems for the week of 7-11 September 2026
The MHRA published six Field Safety Notices for the period 7–11 September 2026, covering devices from six manufacturers. The notices span orthopaedic implant components, a transcatheter heart valve system, an orthopaedic…
Read the full UK MHRA Medicines brief →MHRA updates exceptional use authorisation list with one extension and multiple active authorisations
MHRA published an updated list of medical devices granted exceptional use authorisations on 11 September 2026, adding one extension to reference DEU/002/2026/002. The list governs which non-CE-marked devices may be sold …
Read the full UK MHRA Medicines brief →MHRA updates exceptional use authorisation list with new device entries and expired authorisations
MHRA published its weekly update to the exceptional use authorisation register on September 9, 2026. The update adds Clinisys Inc laboratory information system versions, extends the American Surgical Company authorisatio…
Read the full UK MHRA Medicines brief →MHRA publishes twelve Field Safety Notices across device and IVD categories for the week of 31 August to 4 September 2026
MHRA released a consolidated list of twelve Field Safety Notices dated 31 August to 4 September 2026, covering surgical implants, imaging systems, anesthesia equipment, and diagnostic reagents. Each notice originates fro…
Read the full UK MHRA Medicines brief →MHRA updates suspended and revoked licence list for UK medicines manufacturers and wholesalers
The MHRA updated its public register of suspended and revoked manufacturing and wholesale distribution authorisations on September 9, 2026. The register reflects same-day licence actions and serves as the authoritative s…
Read the full UK MHRA Medicines brief →MHRA-enforced UK restricted medicines list updated to add Raltitrexed, Ramipril, and remove two products
The UK Department of Health and Social Care updated its restricted medicines list on 9 September 2026, adding Raltitrexed and Ramipril across all strengths and forms. Wholesale dealer licence holders face immediate suspe…
Read the full UK MHRA Medicines brief →MHRA publishes September 2026 list of cancelled and terminated UK medicines manufacturing and wholesale dealer licences
The MHRA published its September 2026 update to the standing register of cancelled, terminated, and revoked medicines manufacturing and wholesale dealer licences. Terminations reflect voluntary surrender by licence holde…
Read the full UK MHRA Medicines brief →MHRA publishes 15 Field Safety Notices for medical devices issued 24 to 28 August 2026
The MHRA published a consolidated listing of 15 Field Safety Notices issued between 24 and 28 August 2026, covering devices across anaesthesia, ventilation, infusion, imaging, and diagnostics. Recipients of any listed FS…
Read the full UK MHRA Medicines brief →MHRA issues mandatory filter-use safety directive for parenteral nutrition administration across all care settings
The MHRA published Drug Safety Information DSI/2026/011 on September 2, 2026, directing healthcare professionals to use integrated or add-on filters for all parenteral nutrition administration. The directive follows a fa…
Read the full UK MHRA Medicines brief →MHRA issues patient safety communication requiring filter use for all parenteral nutrition administration across care settings
The MHRA published a Drug Safety Update on September 2, 2026 requiring filter use during parenteral nutrition administration in all care settings, following adverse incidents including a fatal embolism. The maximum pore …
Read the full UK MHRA Medicines brief →UK Government tables three MHRA reform amendments to the Health Bill covering information sharing, regulatory agility, and device licensing
On September 1, 2026, the UK Government tabled three amendments to the Health Bill addressing MHRA information-sharing powers, legislative update mechanisms, and enabling powers for a future medical device licensing regi…
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