The publication of the stable text of the European Union (EU) Medical Devices Regulation (MDR), and the In Vitro Diagnostic Medical Devices Regulation (IVDR), in June 2016 documented political agreement between the three EU Institutions – the Commission, the Parliament, and the Council – on the revision of the European Union legislation for medical devices. The text has now been reviewed for legal and language consistency. Formal publication of the ratified text in the Official Journal is expected in the second quarter of 2017, with entry into force of the two Regulations twenty days later.