MHRA Clinical Investigations Guidance for Medical Devices

The UK has updated its guidance on notifying the Medicines and Healthcare products Regulatory Agency (MHRA) about clinical investigations for medical devices.

Key Changes to the MHRA Clinical Investigations Guidance:

• • Clarified Fees and Payment Process: Detailed information on the fees associated with the notification process and how to make payments.
  • Guidance on Early Terminations and Temporary Halts: New guidance provided for early terminations and temporary halts of clinical investigations in Great Britain (GB) and Northern Ireland (NI).
  • Annex XVI Applications: A clear statement that Annex XVI applications cannot be accepted in GB.

These updates aim to streamline the notification process and provide clearer guidance for sponsors and medical device manufacturers. For more details, visit the MHRA website here.

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If you would like to discuss more about the UK’s MHRA clinical investigations update for medical devices, contact us so our regulatory team can help you.

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