MHRA Guidance on Notifying Clinical Investigations for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance regarding the notification process for clinical investigations of medical devices in the United Kingdom. Manufacturers seeking UKCA, CE, or CE UKNI markings must inform the MHRA at least 60 days before commencing any investigation. The guidance distinguishes between studies in Great Britain and those involving Northern Ireland, providing specific flowcharts and documents to help determine if an application is required. Notably, notifications are not needed for devices already marked for the investigated purpose, and applications for devices with no intended medical purpose under Annex XVI of the EU MDR are not accepted in Great Britain. Exemptions apply to healthcare establishments manufacturing devices in-house for their own patients, unless data is sought for commercial products. The update also outlines fee structures, payment procedures, and options for regulatory advice meetings. Stakeholders are urged to review the latest documents published in August 2025 to ensure compliance with current regulatory standards for clinical study applications.
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