Module 1: Introduction to European Regulations on Medical Devices

EU MDR Publication & Enforcement Timeline


April 5, 2017: The EU Medical Device Regulation was adopted.


May 5, 2017: The Regulation was published in the Official Journal of the European Union.


May 26, 2017: The Regulation entered into force and will apply in parallel with the current medical devices directive MDD 93/42/EEC for a transition period of three years.


December, 2017: The process of re-designating Europe’s Notified Bodies under the new regulation begins. The first designations are expected to be finalized some 12 to 18 months from the date of publication of the legislation.


May 25, 2020: The transition period ends and the Medical Devices Regulation becomes mandatory. But is delayed due to COVID-19.