The Medicines and Healthcare products Regulatory Agency, the UK
competent authority, has published an updated version of guidance relating to clinical investigations. The document applies to manufacturers that intend to carry out clinical investigations in the United Kingdom.
The document covers all aspects of performing and reporting clinical investigations in the United Kingdom and includes a useful Flow Diagram of Clinical Investigation Process and notes on how to handle different classes of devices, according to BSI, a global certification and business services organization.
Copies of the guidance are available for download.Norbert Sparrow
Tags: EU Regulatory