Comments on Council Approach on proposed regulation on In Vitro Diagnostic Medical Devices

EDMA, the voice of the in vitro diagnostic manufacturers in Europe, welcomes the progress in the development of an EU Regulation on In Vitro Diagnostics (IVD), which intends to strengthen the current approval system for in-vitro diagnostics. This regulation will introduce substantial changes to the existing legislation, first introduced in 1998. The Council’s partial general approach of June 2015 still falls short, and requires improvement to fulfil the overarching objective of creating a new specific regulation for in vitro diagnostic medical devices.