Medical Devices Regulation - Trialogues to start soon


In September 2002, the European Commission published its proposals for the revision of the EU medical devices legislation. The existing Directives will be replaced by two regulations, one on medical devices and the other one on in vitro diagnostic medical devices. The proposals follow the ordinary legislative procedure, therefore both the Council and the European Parliament need to adopt the texts.

The Parliament adopted its resolution during a plenary meeting in April 2014, while the Council reached a partial general approach last June.

During the Summer the Council Working Party met to finalise the outstanding issues concerning the preamble of the two drafts, in order to allow inter-institutional negotiations to start.  The first trialogue is scheduled for October (11th); Commission, Parliament and Council are expected to work out a final text by the end of the year or beginning of 2016.  However, finding a common position between the three of them  may prove to be a difficult task given the firm mandate received by the  Luxembourg Presidency to negotiate but at the same time safeguarding the position agreed by the Council in June.

Any questions? Please contact: Fabian Raddatz
Practice Group: Health Care

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