In the United Kingdom, any clinical investigation involving a non-UKCA/CE-marked device that is not yet commercially available must be submitted for approval to MHRA. This applies to both single-site UK trials and UK participants involved in international multi-centre studies. The guidance ensures that trials involving medical devices meet local regulatory expectations and follow internationally accepted ethical and quality standards.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the current requirements for submitting a clinical investigation of a medical device. The guidance explains the application process, documentation, and timelines under UK MDR 2002. Sponsors must ensure compliance with both local legislation and Good Clinical Practice (GCP) standards. The notification procedure applies to all non-UKCA/CE-marked devices under investigation in the UK.
Clinical investigation submission – step-by-step MHRA guide
The sponsor is required to submit:
- a completed CI Notification Form signed by both the sponsor and principal investigator,
- the technical documentation or risk analysis report of the device under investigation,
- a full clinical investigation protocol and informed consent forms (ICFs),
- REC opinion or information on ethics committee submission status,
- manufacturing information, quality system overview, and monitoring strategy.
Timelines and communication
MHRA’s standard assessment period is 60 calendar days from the date of a valid application. If further clarification is needed, the timeline pauses until the requested information is received. All communication must be carried out via email to: [email protected].
Formal obligations and compliance
MHRA emphasises that:
- clinical investigations must comply with ISO 14155 and GCP principles,
- the sponsor is responsible for reporting serious adverse events (SAEs) and submitting a final report,
- notification is mandatory regardless of the intended certification route (UKCA or CE marking).
Why this matters for clinical trial sponsors in the UK
MHRA’s guidance reinforces that regulatory readiness, complete documentation, and proactive communication are critical for timely study approval. As more manufacturers conduct parallel investigations across multiple markets (UK–EU–US), detailed awareness of UK-specific requirements is essential for planning and execution.
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