MHRA releases its AI Airlock Sandbox Phase 2 report, detailing regulatory insights on AI validation, PCCPs, generative AI, and real-world PMS.

The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.

The MHRA has updated its guidance on determining whether a clinical investigation is required for medical devices in Great Britain, covering pre-clinical testing, PMCF, medical purpose, research tools and notification requirements.

The MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices, including classification, custom-made devices and examples.

The MHRA has updated its guidance on custom-made medical devices in Great Britain, covering definitions, conformity assessment, UKCA marking, statements, PMS, vigilance and registration.

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.

The MHRA has updated its guidance on the management and use of in vitro diagnostic point-of-care test devices, including POCT services in primary and secondary care settings.

The MHRA has updated its list of UK approved bodies authorised to undertake conformity assessments for medical devices under the UK MDR 2002.

The MHRA has updated its guidance on clinical investigations for medical devices, including applications, assessment timelines, amendments, reporting requirements and fee waiver information.

The MHRA has published a paper on regulatory-grade data, real-world data and the data infrastructure needed to support safety surveillance and regulatory decision-making.

MHRA guidance on medical device borderlines in Great Britain, covering intended purpose, UKCA scope and manufacturer considerations.

The MHRA has updated its guidance on registering medical devices in Great Britain, clarifying registration requirements, UK Responsible Person obligations, documentation expectations and procedures for managing registered devices.

The MHRA has published the Phase 2 report of its AI Airlock programme, highlighting regulatory challenges related to AI medical devices, AI-powered IVDs, performance evaluation, post-market surveillance and lifecycle change management.

The MHRA has released new visual guidance on UK MDR 2002 conformity assessment routes for medical devices. Learn what Class I, IIa, IIb, III, AIMD, and custom-made device manufacturers need to know for UKCA compliance and GB market access.

MHRA updates its clinical investigations guidance and introduces a 2026–2027 fee waiver pilot for SMEs. Key requirements for medical device manufacturers explained.

MHRA clarifies alignment between the Declaration of Helsinki and amended UK Clinical Trial Regulations effective April 2026. Key impacts for sponsors and manufacturers.

MHRA updates clinical trial record retention rules to 25 years. Key implications for manufacturers, TMF management, and UK regulatory compliance.

MHRA releases updated 2026 guidance on clinical investigations in Great Britain. Key regulatory impacts for medical device manufacturers under UK MDR.

MHRA releases new 2026 guidance on clinical investigation submissions via IRAS. Key requirements, timelines, and implications for manufacturers.

MHRA updates guidance on medical device regulation in Northern Ireland. Key impacts for manufacturers under EU MDR and IVDR.