Clinical investigations for medical devices
Guidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.
UK MHRA · UK
Jurisdiction
UK
Since leaving the EU, the United Kingdom has run its own health regulatory regime. The MHRA licenses medicines and regulates medical devices, including UKCA marking and the future UK medical devices framework, and NICE appraises clinical and cost effectiveness for the NHS.
Regulation
Category
Type · Breadth
Date
Guidance: Ambient voice technology-enabled products
Guidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.
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UK MHRA · UKMHRA data requirements to support regulatory decision making
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UK MHRA · UKGuidance: Approving clinical investigations
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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 · UKGuidance: Medical devices: post-market surveillance requirements
Guidance on interpreting post-market surveillance requirements for medical devices in Great Britain.
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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: 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 · 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 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 · UKGuidance: AI Airlock Phase 2 Cohort
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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
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UK MHRA · UKMedical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
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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: 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 · UKDesignated standards prioritisation
MHRA invites feedback on the use of designated standards for medical devices and IVD devices to inform future regulatory initiatives.
UK MHRA · UKUK Post-Market Surveillance Regulations
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UK MHRA · UKUK New Medical Device Regulation Implementation
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UK MHRA · UKGuidance: Strengthening supply chain cyber security at the MHRA
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UK MHRA · UKNICE evidence standards framework for digital care technologies
NICE adapts its evidence standards framework for digital health technologies to support decision-making for digital care technologies in adult social care.
UK NICE · 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
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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 · UKUK DORS Annual Registration Fee System
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UK MHRA · UKGuidance: In Vitro Diagnostic roadmap
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UK MHRA · UKMHRA Innovation Office: guidance and support
We can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.
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
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UK MHRA · UKMHRA advises quarantine of medical devices supplied without appropriate conformity markings
MHRA alerts to non-compliant medical devices on UK market lacking required conformity markings under UK MDR or EU MDR.
UK MHRA · UKInsulin pumps and continuous glucose monitoring (CGM) equipment: guidance for users on reporting suspected adverse incidents and safety concerns to the MHRA's Yellow Card scheme
New guidance for users of diabetes management equipment on reporting suspected adverse incidents and safety concerns via the Yellow Card scheme.
UK Drug Safety Update · UKMHRA sets out position on regulation of microbiome-based medicinal products
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UK MHRA · UKUK Position Paper on Microbiome-Based Medicinal Products (MBMPs)
MHRA guidance to support development and licensing of microbiome-based medicinal products in the UK.
UK MHRA · UKGuidance: Clinical trials: Phase 1, 14-Day Pilot Programme
MHRA pilot programme to deliver first-wave regulatory assessment of qualifying Phase 1 applications within 14 calendar days by end of 2026.
UK MHRA · UKGuidance: Medical devices: legal requirements for specific medical products
Guidance on regulatory requirements applicable to prosthetic, orthotic and ophthalmic devices.
UK MHRA · UKGuidance: Health Institution Exemption for general medical devices
Guidance for health institutions manufacturing general medical devices under the Health Institution Exemption.
UK MHRA · UKGuidance: Clinical trials that include an in vitro diagnostic device
Guidance on submitting applications for clinical trials that include an in vitro diagnostic device.
UK MHRA · UK
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