On May 25, 2016, the European Parliament, European Council and the European Commission agreed on new rules regarding the approval and surveillance of medical devices and in vitro diagnostics for the European market.
The agreement on the new rules is still subject to approval by the Council's Permanent Representatives Committee and the Parliament's ENVI committee; however, the agreement will most likely become the basis of the text of new European regulations governing the marketing of medical devices and in vitro diagnostics.
Please see full publication below for more information.
