Position Paper

EBE-EPEMED Position Paper on Companion Diagnostics

08 Apr 2015

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[1]. 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


[1] http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm

2017-08-30T09:29:15+00:00April 8, 2015|