On March 7, 2017, the EU Council unanimously adopted the text of the proposed Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation (IVDR). The next step is a vote by the European Parliament in April. If approved the Official Journal of the European Union will publish the regulations and the transition period will begin.
The regulations replace the current Medical Device Directive, Active Implantable Directive, and the In-vitro Diagnostic Directive. The MDR has a three-year transition period and the IVDR has a five-year transition period.