News and communications from MHRA
- MHRA approves Xevudy (sotrovimab), a COVID-19 treatment found to cut hospitalisation and death by 79%
- Precautionary recall of specific batches of blood pressure drug irbesartan
- MHRA statement on expansion of the COVID-19 vaccination booster programme
- MHRA welcomes today’s announcement by the JCVI
- Life-saving adrenaline auto-injectors could become available in public places
- Labelling error leads to retail-level recall of cold and flu medicine
- First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA
- MHRA’s new Chief Healthcare Quality and Access Officer begins important role
- Every report counts: support the Yellow Card scheme by reporting suspected side effects
- MHRA publishes clear guidance to support bringing e-cigarettes to market as licensed therapies
- UK, USA and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software
- Tesco Max All-In-One Chesty Cough & Cold Lemon Sachets are being recalled
- Innovative Licensing and Access Pathway (ILAP): New partner announcement
- Transforming the regulation of software and artificial intelligence as a medical device
- MHRA launches public consultation on future of medical device regulation
Alerts and recalls for drugs and medical devices
- Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)
- Masks: type IIR from Cardinal Health – destroy affected lots (MDA/2020/021)
- Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)
- Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)
- Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)
- Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation (MDA/2020/017)
- Philips HeartStart MRx Monitor/Defibrillators - may fail to deliver therapy without alerting the user to a fault in the event of internal damage (MDA/2020/016)
- Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable (MDA/2020/015)
- Pilling Clear Advantage aortic punch – risk of infection due to packaging failure (MDA/2020/014)
- COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013)
- Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)
- Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)
- Spinal implant: MAGEC System Model X rods – risk of failure in use (MDA/2020/010)
- Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models
- Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users (MDA/2020/008)
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