Clinical investigations in the EU: changes and challenges
This article was originally published in Clinica
Executive Summary
Medical device manufacturers are faced with a major challenge in keeping up to date with the profusion of developments that are occurring in Europe with the regulation of clinical investigations. Many changes have recently been made or are in the process of being made, both at European level and at national level, Danielle Giroud, founder and president of d-Target, told a recent Management Forum meeting in London on February 2 on GCP for Medical Devices in Europe. And manufacturers would be wise to monitor these changes, since they have a huge impact on the variation in conditions for carrying out clinical investigations in each country, writes Amanda Maxwell