Register medical devices to place on the market
MHRA guidance on the registration process and requirements for medical devices in Great Britain and Northern Ireland.
UK MHRA · UKUK MHRA
Regulation
Category
Type
Date
Guidance: What the National Commission's recommendations mean for you
Guidance on implementing National Commission recommendations to improve safety, clarity and fairness in healthcare AI across the UK.
UK MHRA · UKGovernment Response to the National Commission's Recommendations on the Regulation of AI in Healthcare
Government response clarifying how it intends to implement the independent National Commission's recommendations on AI regulation in healthcare.
UK MHRA · UKNational Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework
Commission recommends a future regulatory framework for AI in healthcare, advising government on governance and oversight mechanisms.
UK MHRA · UKPatient reported outcomes (PROs) resources for digital mental health technologies
Resources to help developers use patient-reported outcomes in digital mental health technologies for evidence generation, monitoring and user safety.
UK MHRA · UKGuidance: Good machine learning practice for medical device development
Ten guiding principles for developing machine learning-based medical devices.
UK MHRA · UKClinical investigations for medical devices
Guidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.
UK MHRA · UKGuidance: Ambient voice technology-enabled products
Guidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.
UK MHRA · UKMHRA clarifies regulatory status of ambient voice technologies used in the NHS
MHRA guidance clarifies how medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKGuidance: Digital mental health technology: qualification and classification
Guidance to help manufacturers of digital mental health technologies determine regulatory qualification and appropriate device classification.
UK MHRA · UKMHRA Real-World Evidence: knowledge and guidance
MHRA guidance on the use of real-world data and real-world evidence in regulatory decision-making for medicines and medical devices.
UK MHRA · UKMHRA regulatory reform amendments tabled in Government's Health Bill
Proposed amendments to enable information sharing, regulatory reform, and development of a future medical device licensing regime.
UK MHRA · UKGuidance: AI Airlock Phase 3 application
Applications for phase 3 of the AI Airlock regulatory sandbox are now open.
UK MHRA · UKGuidance: Approving clinical investigations
MHRA guidance on the approval process and criteria for clinical investigations of medical devices.
UK MHRA · UKGuidance: Timelines for acceptance of CE marked medical devices in Great Britain
MHRA guidance on transitional arrangements and timelines for accepting CE marked medical devices in GB.
UK MHRA · UKNational Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings
Findings from the National Commission's call for evidence and research activities on AI regulation in healthcare.
UK MHRA · UKMHRA seeks input on AI regulation at 'pivotal moment' for healthcare
UK MHRA National Commission is seeking evidence to shape regulation of AI in healthcare and support an AI-enabled NHS.
UK MHRA · UKRegulation of AI in Healthcare
MHRA seeks evidence on AI regulation in healthcare to inform the National Commission's recommendations.
UK MHRA · UKGuidance: Borderline products: medical devices and other products
MHRA guidance on how it determines whether a borderline product meets the definition of a medical device and whether device regulations apply.
UK MHRA · UKGuidance: Clinical investigations: investigators' responsibilities
Guidance on investigator obligations and requirements for clinical investigations of medical devices under MHRA regulation.
UK MHRA · UKGuidance: Medical devices that need a clinical investigation
Explains how to determine whether a medical device requires a clinical investigation or qualifies for exemption under regulations.
UK MHRA · UKRegulation of medical devices in Northern Ireland
MHRA guidance on the regulatory framework and applicable legislation for medical device manufacturers and suppliers operating in Northern Ireland.
UK MHRA · UKDevices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
MHRA enforcement notice requiring removal and quarantine of medical devices supplied without valid UKCA/CE markings or certification.
UK MHRA · UKGuidance: The Centres of Excellence for Regulatory Science and Innovation programme (CERSIs)
A national programme to drive healthcare advancements and accelerate patient access to innovation and new treatments.
UK MHRA · UKMHRA issues new guidance for people using mental health apps and technologies
MHRA publishes online resources to help the public and professionals understand safe, effective digital mental health technologies.
UK MHRA · UKMHRA invites views on proposed changes to medical device regulation
MHRA publishes new pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market and invites stakeholder views.
UK MHRA · UKPre-market medical devices regulation – stakeholder impact survey
MHRA seeks stakeholder evidence on proposed GB pre-market medical device and IVD regulation changes to inform impact assessment.
UK MHRA · UKMedical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
MHRA invites views on proposals for recognising CE marked medical devices in Great Britain.
UK MHRA · UKBeyond ADMET: AI for medicines safety - survey
MHRA and RIO invite stakeholder input on artificial intelligence use in medicines development and safety.
UK MHRA · UKLondon Region I MHRA Regulatory Sandbox: call for expressions of interest
MHRA invites expressions of interest from AI-enabled medical device manufacturers and NHS providers to participate in a regulatory sandbox.
UK MHRA · UKGuidance: Innovation Accelerator
MHRA establishes an Innovation Accelerator programme offering scientific expertise, regulatory guidance and enhanced advice to developers of innovative health products.
UK MHRA · UKRadiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems
MHRA guidance on RF safety risks in wireless CTG systems, including signal crossover, erroneous traces and dropouts.
UK MHRA · UKGuidance: Medical devices: post-market surveillance requirements
Guidance on interpreting post-market surveillance requirements for medical devices in Great Britain.
UK MHRA · UKMHRA data requirements to support regulatory decision making
MHRA sets out data requirements and governance expectations for the UK Health Data Research Service to enable regulatory decision-making.
UK MHRA · UKGuidance: Strengthening supply chain cyber security at the MHRA
MHRA invites suppliers to join Risk Ledger and complete security profiles to strengthen supply chain cyber security.
UK MHRA · UKGuidance: Clinical investigations: compiling a submission
Guidance on how to notify the MHRA of a planned clinical investigation of a medical device.
UK MHRA · UKCOVID-19 test approval: how to apply
Guidance for manufacturers and distributors on the application process for COVID-19 test device approval in the UK market.
UK MHRA · UKGuidance: The Innovative Devices Access Pathway (IDAP)
IDAP pilot accelerates development and market integration of innovative medical devices addressing unmet NHS clinical needs.
UK MHRA · UKGuidance: Medical devices: Standardised format for the post market surveillance report
MHRA provides standardised format and recommendations for manufacturers preparing post-market surveillance reports.
UK MHRA · UKMHRA Strategy to 2030: guidance on implementation
A series of explainers to help you understand the parts of the MHRA Strategy to 2030 most relevant to you, and what they mean in practice.
UK MHRA · UKGuidance: AI Airlock Phase 2 Cohort
Phase 2 of the Airlock programme will include seven additional AI-powered technologies for clinical documentation, cancer diagnostics, eye disease detection, and obesity treatment.
UK MHRA · UKGuidance: In Vitro Diagnostic roadmap
MHRA sets out deliverables and timelines to support safe development of in vitro diagnostic medical devices.
UK MHRA · UKGuidance: Custom-made medical devices in Great Britain
Explains regulatory compliance requirements for manufacturers of custom-made medical devices.
UK MHRA · UKGuidance: In vitro diagnostic point-of-care test devices
Guidance on management and use of point-of-care testing in vitro diagnostic devices.
UK MHRA · UKGuidance: Clinical investigations for electrically powered devices
Guidance on information requirements for notifying the MHRA of clinical investigation plans for electrically powered devices.
UK MHRA · UKGuidance: Clinical investigations: biological safety assessments
Guidance on conducting biological safety evaluation required before undertaking clinical investigations for medical devices.
UK MHRA · UKGuidance: Clinical investigations: statistical considerations
Guidance on statistical data requirements for clinical investigations of medical devices.
UK MHRA · UKMHRA updates guidance on the Health Institution Exemption to support safe use of medical devices
MHRA updated guidance on the Health Institution Exemption to help NHS Trusts and health institutions safely design and manufacture general medical devices.
UK MHRA · UKGuidance: MHRA Innovation Accelerator
The Innovation Accelerator provides innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service.
UK MHRA · UKGuidance: Medical devices: legal requirements for specific medical products
Guidance on regulatory requirements applicable to prosthetic, orthotic and ophthalmic devices.
UK MHRA · UK
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