Clinical Investigations for Electrically Powered Devices
Summary
The MHRA has published guidance dated 30 March 2026 for manufacturers and sponsors undertaking clinical investigations of electrically powered medical devices. The document explains the additional information that must be provided to MHRA when submitting a clinical investigation notification. This guidance applies to any party seeking to conduct clinical research on powered medical devices in the UK market.
“This guidance provides advice for people undertaking a clinical investigation of a medical device that is electrically powered, explaining the extra information that you should provide in your application.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
The MHRA has published guidance for persons undertaking a clinical investigation of a medical device that is electrically powered, specifying the additional information required in a notification application to the agency. The guidance, effective 30 March 2026, explains what applicants must provide beyond standard clinical investigation notification requirements.
Manufacturers, sponsors, and clinical investigators of electrically powered medical devices should review the guidance to ensure their notification submissions to MHRA include all required additional information, ensuring compliance with current regulatory expectations before initiating UK-based clinical research on powered devices.
Archived snapshot
Mar 30, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Guidance
Clinical investigations for electrically powered devices
Detailing the information you need to provide the MHRA when you notify us of your clinical investigation plans.
From: Medicines and Healthcare products Regulatory Agency Published 30 March 2026 Get emails about this page
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Clinical investigations for electrically powered devices
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This guidance provides advice for people undertaking a clinical investigation of a medical device that is electrically powered, explaining the extra information that you should provide in your application.
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Published 30 March 2026
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