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UK MHRA: Notify MHRA About a Clinical Investigation for a Medical Device

Yesterday (26 April 2024) the UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Notify MHRA About a Clinical Investigation for a Medical Device" which details how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

One key requirement for conducting a clinical investigation of a medical device is notifying the MHRA about the investigation. The MHRA provides detailed guidance on the process of notifying them about a clinical investigation for a medical device.

 A clinical investigation is a systematic study of a medical device in humans to assess its safety, performance, and effectiveness.

This is conducted to generate clinical data that supports the safety and performance of a medical device. A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose under investigation.

The Integrated Research Application System (IRAS) is used to submit applications electronically, and once MHRA receives the documents and validates them, they will inform the applicant within five working days if there are any problems with the 60-day assessment. The 60-day assessment will begin when MHRA receives a valid response if any issues are raised.

During the assessment, experts will assess the safety and performance of your device as well as the design of the clinical investigation to be carried out. The sponsor must report any adverse events or other relevant information to the MHRA during the course of the investigation At the conclusion of the investigation, the sponsor must submit a completion report to the MHRA summarizing the findings.

By following this guidance and submitting a thorough notification, sponsors can contribute to the generation of valuable clinical data that supports the safety and effectiveness of medical devices.

Also check out this guidance on Medical devices: UK approved bodies.


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