On May 25, 2016 the European Commission published a press release in order to state that the Dutch Presidency of the Council and the representatives of European Parliament have finally reached a “political agreement” on the new regulations for medical, implantable and IVD devices. This agreement has still to be formally approved by the Council and the Parliament, but without further difficulties.
By that, it is extremely likely that new regulations will enter into force before the end of 2016, after a three year transition period for Medical Devices (MD) and active implantable Medical Devices (AIMD), and a five year transition period for in vitro diagnostic Medical Devices (IVDD).
For further information:
