The European Commission has reported that ministers of all EU countries have agreed on a general approach to the new medical devices and in vitro diagnostic devices Regulations. This approach is intended to serve as a basis for upcoming, informal three-way discussions ('trialogue') between the European Parliament, The Council and the European Commission.
According to a Eucomed position paper, there are five areas of the proposed legislation that merit particular attention in the trialogue: the scrutiny mechanism; clinical evidence; re-use of single-use medical devices; hazardous substances; and, unnecessary added complexity and disproportionate measures.
The trialogue will take place during the Luxembourg Presidency in the last part of 2015. If this is successful in producing a compromise text, the Dutch presidency is expected to be able to bring the new Regulations into law in the first half of 2016.