MHRA Updates Guidance on Submitting Clinical Investigation Proposals for Assessment
MHRA has updated its guidance on submitting clinical investigation proposals, covering GB and Northern Ireland requirements, IRAS submission, supporting documentation, fees, device evidence, software, biological safety and sterilisation.
MHRA Updates Guidance on Registering Medical Devices for the UK Market
The MHRA has updated its guidance on registering medical devices, IVDs, custom-made devices, systems and procedure packs for the Great Britain and Northern Ireland markets.
MHRA Updates Guidance on Clinical Investigations and Introduces 2026–2027 Fee Waiver Pilot
MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.
MHRA Updates Guidance on Regulation of Medical Devices in Northern Ireland
MHRA updates guidance on medical device regulation in Northern Ireland. Key impacts for manufacturers under EU MDR and IVDR.