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MHRA updates clinical investigation notification guidance for medical devices

🇬🇧 MHRA · Fri 06 Nov 2026

The UK regulator's guidance page, last updated 6 November 2026, sets out the 60-day notice rule, fees and payment steps for sponsors planning device studies.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on notifying the agency of an intended clinical investigation of a medical device. The page was first published on 18 December 2014 and was last updated on 6 November 2026. The source does not say which parts of the page changed in this latest update.

The guidance states that sponsors may need a clinical investigation as part of obtaining a UKCA, CE or CE UKNI mark. The MHRA must be informed at least 60 days before an investigation starts. No notification is needed where the device already carries one of those marks for the purpose being investigated.

To decide whether an application is needed for studies in Great Britain, sponsors should use the MHRA flow chart and accompanying guidance. The page notes that updated versions of these documents were published in August 2025 and asks applicants to review the latest versions. Studies in Northern Ireland, or in Great Britain and Northern Ireland, have a separate flow chart and guidance. The page also says applications under Annex XVI of the EU Medical Device Regulation 2017/745, for devices with no intended medical purpose, cannot be accepted in Great Britain.

For healthcare establishments, no notification is required for a device made in-house for the establishment's own patients with no objective of placing it on the market. Notification may be needed if an in-house device is supplied to another organisation to generate data supporting a commercial product. The page points to the Health Institution Exemption for general medical devices.

On fees, the page refers applicants to section 7 of the MHRA fees page, which also covers Northern Ireland device studies. Under the Medical Devices Regulations 2002, the fee is payable when the notice is given and must accompany it. The MHRA raises an invoice, asks for a purchase order number and the name of the payer, and requires proof of payment quoting the CI reference. It will not issue a final decision, whether approval or objection, until payment is received. Easements exist for small and medium-sized enterprises (SMEs), who must supply the MHRA SME approval letter when they submit. The MHRA also offers paid regulatory advice meetings, though it cannot review individual documents.

What it means for your team

  • Check the MHRA page directly to identify what changed on 6 November 2026, as the update is not described in the source.
  • Build the 60-day pre-start notice period into study timelines for devices not already marked for the investigated purpose.
  • Re-run the flow chart and guidance, including the August 2025 versions, to confirm whether an application is required and which GB or Northern Ireland route applies.
  • Arrange payment early: supply a purchase order number and proof of payment, because the MHRA will not issue a decision until it has received the fee.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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