MHRA Guidance & Safety

MHRA Approves Zanidatamab for HER2+ Biliary Tract Cancer

The MHRA has approved zanidatamab (Ziihera) for adult patients with HER2-positive biliary tract cancer that has progressed after previous treatment. This approval provides a new treatment option for a specific patient population with an unmet clinical need.

MHRA: UK Medical Device Testing Hits Record High, Backs AI

The UK's MHRA reported a 17% increase in approved medical device clinical investigations in 2025. The agency is implementing measures to support innovation, including a fee waiver pilot for small firms and enhanced support for AI and neurotechnology.

MHRA Medical Device Safety Notices

The MHRA has issued a list of eight medical device safety notices published between February 9-13, 2026. These notices cover various devices including ventilator circuits, tissue reconstructive material, and PET/CT scanners. The MHRA publishes these for informational purposes.

MHRA Consultation on Indefinite Recognition of CE-Marked Medical Devices

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks feedback on extending current transitional arrangements and introducing an international reliance route to ensure continued supply and patient access to medical technologies. The deadline for feedback is April 10, 2026.

MHRA Consultation on CE Marked Medical Device Recognition

The MHRA has launched a consultation on proposals for the indefinite recognition of CE-marked medical devices in Great Britain. The consultation seeks views on extending transitional arrangements for MDD-compliant devices and indefinitely recognising EU MDR/IVDR compliant devices, with a comment deadline of April 10.

MHRA Seizes 20 Million Illegal ED Pills, Warns Against Online Buys

The MHRA announced the seizure of nearly 20 million illegal erectile dysfunction pills between 2021 and 2025, including 4.4 million in 2025 alone. The agency is warning the public against purchasing unauthorized medicines online due to significant health risks.

MHRA Restricts Chikungunya Vaccine IXCHIQ Use

The MHRA has introduced additional restrictions on the use of the Chikungunya vaccine IXCHIQ. The vaccine is now restricted to adults aged 18-59 without specific pre-existing health conditions, following reports of serious adverse reactions, including fatalities. Healthcare professionals must conduct a benefit-risk assessment before administration.

MHRA Medical Devices Exceptional Use Authorisations List Updated

The UK's MHRA has updated its list of medical devices granted exceptional use authorisations. This guidance document provides transparency on manufacturers and devices that have received exemptions, including those whose authorisations have expired or been cancelled.

MHRA: Stop using non-sterile alcohol-free wipes due to infection risk

The MHRA and UKHSA are advising the public not to use four specific non-sterile alcohol-free wipe products due to contamination with Burkholderia stabilis bacteria. These products have been withdrawn from sale, but may still be in homes, and are linked to 59 cases, including one death.

MHRA: Quetiapine Oral Suspension Recalled Due to Incorrect Active Ingredient

The MHRA has issued a recall for all batches of quetiapine oral suspension manufactured by Eaststone Limited due to an incorrect amount of the active ingredient, potentially leading to overdose. Approximately 166 bottles manufactured between October 2025 and January 2026 are affected. Patients are advised not to stop medication without consulting a healthcare professional.