Special IVD Issues

The impact of the new EU IVD-Regulation on the IVD industry has been described as a paradigm shift. Beyond the revolution of the new classification rules and the end of the self-certification era this presentation will explore the practical consequences on IVD manufacturers and will provide some hints on how to prepare for compliance – or, for those already on such a path, will provide an opportunity to check whether their course has been set on the right direction.