EBE – EFPIA - EPEMED - EDCA position paper on Commission Proposal for a Regulation on In Vitro Diagnostic Medical Devices

26 Apr 2013

EBE, EFPIA, EPEMED and EDCA believe that the Commission Proposal is an important step to ensure a harmonized approach to regulating in-vitro diagnostic medical devices across the EU. These 4 associations (hereinafter “The Associations”), which together represent a significant portion of the universe of European biotechnology, pharmaceutical and medical diagnostic companies of all sizes, feel that the Proposal strikes a fine balance in ensuring the imperative of patient safety without compromising the need for innovation in Europe. The review of the Proposal by Parliament and Council should keep this balance intact.

Key Messages on the Commission Proposal for a Regulation on In Vitro Diagnostic Medical Devices  Focus Companion Diagnostics