Earlier today (17 July, 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Notify the MHRA about a Clinical Investigation for a Medical Device" that outlines how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
The MHRA requires notification before you start a clinical investigation for a medical device. This notification helps the MHRA assess the safety and performance of the device and ensures compliance with regulations. The applicant can start your application via IRAS.
Manufacturers, sponsors, or their representatives should submit the notification to the MHRA. This includes those responsible for conducting the clinical investigation. In case you are applying for a clinical investigation of a medical device, the regulatory handlers at MHRA will verify the application and validate if it meets the Validation Checklist- GB New Submissions.
See information for clinical investigators for what is required by clinicians involved in the investigation. MHRA will acknowledge the documents after they have been validated within 5 working days to confirm the 60-day assessment has begun or if any issues arise. If any issues are raised, the 60-day assessment will begin as soon as a valid response is received.
The MHRA should be notified of all serious adverse events involving devices in clinical trials within Great Britain, regardless of whether they are initially perceived as device/procedure-related.
To obtain MHRA approval for a clinical investigation, in addition to reporting individual serious adverse events as described above, please provide Quarterly Summary Reports (template) and Annual Reports providing an update on the latest safety profile of the study.
Click this LINK to know more about the Assessment, Coordinated assessment pathway process and many more.
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