Last Thursday (11 May 2023) 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 provides detailed instructions on How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
To obtain a UKCA / CE / CE UKNI marking for your medical device, the manufacturer/sponsor may be required to conduct a clinical investigation. Also must notify the MHRA sixty days before you start your investigation if you intend to do so.
A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.
When MHRA receives an application for a clinical investigation of a medical device the regulatory handers will validate the application against the Validation Checklist- GB New Submissions and this checklist will support in submitting a valid application.
Applications are submitted electronically using the Integrated Research Application System (IRAS) and must follow the guidance on compiling a submission and guidance for manufacturers when preparing the notification application.
When the MHRA has received the documents and validated them, they will acknowledge within 5 working days to confirm that the 60-day assessment has started or will let know of any issues. If there are any issues raised, the 60-day assessment will start when we receive a valid response.
During the assessment, experts will evaluate the safety and performance of the device as well as the design of the clinical investigation to be conducted. The decision letter will be sent by the 60th day with a decision ('objection' or 'no objection') on whether or not to conduct the clinical investigation.
Click this LINK to know more about Notify the MHRA about a Clinical Investigation for a Medical Device.
Комментарии