Update: On 23 April 2020, the European Parliament and the Council of the EU adopted a proposal to extend the transitional period of the Medical Devices Regulation by one year - until 26 May 2021.
This measure aims to avoid shortages of medical devices during the ongoing COVID-19 pandemic due to the limited capacity of national competent authorities or notified bodies to implement the Regulation. EMA will update its regulatory guidance in June 2020 to reflect the new date of application of the Regulation.
|