In early April the EU Parliament voted to enact the Medical Device Regulations (MDR) and the In Vitro Diagnostic Regulations (IVDR). The regulations are due to be published in the Official Journal of the European Union in May 2017. Following publication, there will be a three year transition period for the MDR and a five year transition period for the IVDR. These regulations will therefore not be fully enacted until approximately June 2020 and June 2022, respectively.
For more information on the approval and to review a copy of the draft regulation please follow the attached link.