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Information about the MHRA's duties and how you can report a non-compliant medical device.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Information for clinicians and patients.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
Guidance on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Information about how approved bodies help regulate medical devices and how to apply for approval.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
A poster explaining the different symbols used on medical devices.
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Information about suspected side effects of e-cigarettes and how to report side effects.
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