Progress on the revised Medical Devices Regulation

Health Ministers of the EU Member States reached a partial general approach for the proposed Regulations on medical devices and on in vitro diagnostic medical devices.

The revision of the EU medical devices legislation started in September 2012, with the publication of the Commission’s proposals for two Regulations, one on medical devices and the other one on in vitro diagnostic medical devices, which will replace the existing Directives. According to the ordinary legislative procedure, both the Council and the European Parliament need to adopt the text. While the EP had a vote on its resolution in April 2014, the Council reached a partial general approach only this June.

The Council Working Party will continue the discussions on the recitals of the two proposed regulations in order to reach a complete general approach and begin negotiations with the European Parliament, which are most likely to happen in early Autumn. The so called trilogue between the Council and the Parliament is expected to be demanding, because of the divergent positions of the two institutions on several elements of the draft regulations.

For the time being it is not possible to determine an exact timeline. At the beginning of July Member States’ experts will be convened by the Luxembourg Presidency, which will present its priorities and, possibly, its agenda for the next six months.

Further articles: Update on EU Regulations on Medical Devices, Revision of the EU Medical Devices Legislation – state of play