MHRA: GB Mandates Clinical Investigation Medical Device Notification

• Medical device manufacturers must notify the MHRA at least 60 days before starting a clinical investigation in Great Britain.
• Updated guidance documents were published by the MHRA in August 2025, requiring review for all subsequent applications.
• Applications for devices without a medical purpose under MDR Annex XVI cannot be accepted in Great Britain.
• Fees for clinical investigations are payable with the application, and a final regulatory decision is contingent on payment receipt.
• The MHRA offers SME fee waivers and an extended fee waiver program for eligible small and micro-sized UK enterprises.

A final regulatory decision, whether an approval or an objection letter, will not be issued until the MHRA has received confirmation of payment.

Medical device manufacturers operating in Great Britain must adhere to specific regulatory protocols when planning clinical investigations. A crucial step involves providing the Medicines and Healthcare products Regulatory Agency (MHRA) with advance notice of any such study. This mandatory MHRA clinical investigation medical device notification is a prerequisite, particularly when the investigation aims to support the acquisition of a UKCA, CE, or CE UKNI marking for the device.

Companies are required to inform the MHRA at least 60 days before commencing any clinical investigation. The agency provides distinct guidance documents and flowcharts to assist in determining the necessity of an application, depending on the study's geographical scope. For UK medical device clinical investigation activities confined to Great Britain, a dedicated set of documents should be consulted. Conversely, investigations spanning Northern Ireland, or both Great Britain and Northern Ireland, necessitate reference to guidance specifically outlined in the Northern Ireland section of the MHRA's resources.

Staying abreast of the latest regulatory updates is essential for compliance. The MHRA issued revised versions of its clinical investigation guidance and flowcharts in August 2025, and all applicants are expected to review and understand these updated materials for any applications submitted from that date forward. It is important to note that an MHRA notification for medical device studies is not required for devices that already possess a UKCA, CE, or CE UKNI mark for the specific purpose being investigated.

Furthermore, a significant restriction applies to certain types of devices: applications under Annex XVI of the Medical Device Regulation (EU) 2017/745, which pertain to devices without an intended medical purpose, cannot be processed or accepted within Great Britain. Manufacturers should also explore the Health Institution Exemption for general medical devices, as this may provide an avenue for exemption from notification requirements depending on the study's characteristics. Detailed information on this exemption is available through the MHRA's published resources.

Undertaking a clinical investigation involves specific financial obligations, as outlined by the Medical Devices Regulations 2002 fees. These fees are due concurrently with the submission of the notice to the Secretary of State. The MHRA's fee schedule encompasses applications for device studies conducted in Northern Ireland as well. To facilitate payment, the MHRA issues an invoice, for which applicants should promptly provide a purchase order number and confirm the party responsible for payment.

Crucially, a final regulatory decision, whether an approval or an objection letter, will not be issued until the MHRA has received confirmation of payment. Evidence of payment, including the MHRA reference (CI/XXXX/XXX), must be sent via email to CI-applications@mhra.gov.uk and the assigned Regulatory Handler. Recognizing the challenges faced by smaller entities, the MHRA offers SME fee waivers for clinical investigations. To qualify for these easements, an applicant must submit an MHRA SME approval letter at the time of application. Additionally, the agency is extending its fee waiver program into the 2026-2027 period, commencing April 20, 2026, making ten application fee waivers available to eligible small and micro-sized UK enterprises, aiming to foster innovation and patient access by reducing regulatory costs.

For those navigating the complexities of medical device regulation, the MHRA clinical investigations team provides valuable support through comprehensive device regulatory advice meetings. These sessions are designed to offer guidance on the broader regulatory landscape, though it is important to understand that the team cannot undertake reviews of individual documents. Companies seeking medical device regulatory advice in GB can request a meeting by contacting the Head of Clinical Investigations, Mark Grumbridge, at mark.grumbridge@mhra.gov.uk.

It is important to note that these regulatory advice meetings incur charges, details of which are available in Section 7 of the MHRA's fees page. For specific inquiries related to clinical investigation applications, the general contact email is info@mhra.gov.uk, with "clinical investigation enquiry" specified in the subject line. This structured approach ensures that manufacturers can access the necessary expertise to comply with the MHRA's requirements effectively.

Lawyers and compliance officers advising medical device manufacturers in Great Britain must ensure their clients comply with the MHRA's updated guidance, including the mandatory 60-day pre-investigation notification period, specific application processes for GB versus Northern Ireland, and the fee structure, while also being aware of available SME fee waivers and the inability to accept Annex XVI applications for devices without medical purpose in GB.

Source: Original reporting via GOV.UK guidance