EBE-EPEMED Position Paper on Companion Diagnostics
In September 2012, the Commission proposed a framework that defines how medical devices (MDs) and in-vitro diagnostics (IVDs) may be placed on the EU market. Subsequently, the Parliament has made a number of suggestions for changes to the original text. In light of the Council’s on-going discussion, EBE and EPEMED would like to share some industry thoughts specifically related to the Regulation of companion diagnostics (CDx).
Read the position paper here