Position paper

Revision of Directive 98/79/ECON In Vitro Diagnostic Medical Devices

EDMA, the voice of the in vitro diagnostic manufacturers in Europe, welcomes the revision of the EU In Vitro Diagnostics (IVD) Directive and the intention to strengthen the current approval system for in-vitro diagnostics for the sake of patient safety, whilst still guaranteeing a competitive and innovative environment for manufacturers.