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
Source
UK MHRA
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.
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 · 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 · 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 · 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: Innovation Accelerator
MHRA establishes an Innovation Accelerator programme offering scientific expertise, regulatory guidance and enhanced advice to developers of innovative health products.
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 · 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: 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 · UKGuidance: Medical devices: post-market surveillance requirements
Guidance on interpreting post-market surveillance requirements for medical devices in Great Britain.
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: 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
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 · 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 · 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 · 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: In Vitro Diagnostic roadmap
MHRA sets out deliverables and timelines to support safe development of in vitro diagnostic medical devices.
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
MHRA updated guidance on the Health Institution Exemption to help NHS Trusts and health institutions safely design and manufacture general medical devices.
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 · UKMHRA sets out position on regulation of microbiome-based medicinal products
MHRA clarifies the UK licensing route for microbiome-based medicines to support developer access.
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 · UKGuidance: Archiving and retention of clinical trial records
Guidance on clinical trial record retention and archiving requirements covering ownership, data integrity, and transitional provisions.
UK MHRA · UKConsultation on the International Council for Harmonisation Guideline Q3E for Extractables and Leachables
MHRA seeks stakeholder feedback on ICH Q3E guideline for assessment and control of extractables and leachables.
UK MHRA · UKGuidance: Paclitaxel drug-coated balloons and drug-eluting stents
Expert Advisory Group recommendations on paclitaxel balloon catheters and stents for peripheral arterial disease treatment.
UK MHRA · UKGuidance: Regulatory considerations for therapeutic use of bacteriophages in the UK
Clarifies which regulatory guidelines apply to the development of phage therapeutic products in the UK.
UK MHRA · UKAI Airlock Sandbox Phase 2 Programme Report
The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
UK MHRA · UKPioneering AI health innovations regulatory sandbox launched
UK MHRA launches a regulatory sandbox in London to test AI-enabled devices in real-world environments.
UK MHRA · UK
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