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UK MHRA Guidance: Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission
Clinical investigations are an essential part of demonstrating the safety and performance of medical devices before they are placed on the market. Organizations conducting investigations in Great Britain must ensure that studies are appropriately planned, approved, and supported with complete regulatory documentation. The guidance documents Clinical Investigations in Great Britain, Approving Clinical Investigations, and Compiling a Submission outline the regulatory framework,
Sharan Murugan
2 hours ago2 min read