How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Similar Posts
Guidance: AI Airlock Simulation Workshops
Key insights of three simulation workshops from the AI Airlock pilot testing programme. Please note that these documents are not formal guidance.
Decision: Advertising Investigations: January 2026
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
Decision: Advertising Investigations: May 2025
Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.
Concizumab approved to prevent or reduce the frequency of bleeding episodes in people aged 12 years and older with haemophilia A or B with inhibitors
As with any medicine, the MHRA will keep the safety and effectiveness of concizumab under close review.
Project Orbis
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Medicines: get scientific advice from the MHRA
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.