compiling a submission to MHRA - GOV.UK
Guidance on legislation Clinical investigations of medical devices . compiling a submission to MHRA. MHRA Guidance on legislation Contents 2. Submitting a clinical investigation for MHRA assessment ........................................ ........................ 4. Prior to notifying the MHRA of a clinical investigation ........................................ ............................... 5. IRAS Form and supporting documentation required ........................................ ................................. 7. MHRA Devices submission checklist on IRAS ........................................ .................................. 7. Documentation required for all applications ........................................ ....................................... 7. 1. Covering letter on headed paper.
1. Applications must be made via the Integrated Research Application System (IRAS). 2. Complete the Clinical Investigation Application form on IRAS and upload the relevant supporting documents onto IRAS. Follow the instructions on IRAS on how to submit the application.
Download compiling a submission to MHRA - GOV.UK
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