Medical devices play a significant role in the field of global health. The Medical Devices Regulation (2017/745-MDR) and the In Vitro Diagnostic Regulation (2017/746-IVDR) entered into force in 2017, with a transition period of three years.

On 23 April, the Council and the Parliament of the European Union adopted Regulation 2020/561 amending the Regulation on medical devices (Regulation (EU) 2017/745 on medical devices), regarding application dates of certain of its provisions. This Regulation enters into force on the day of its publication in the Official Journal of the European Union and postpones the date of application of most MDR provisions by one year.

The In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) corresponding date of application remains the same (May 2022).