Tag Archives: 2021

MDR: the Postponement to 2021 is Official

On April 24, 2020 the new Regulation (EU) 2020/561 officially entered into force, postponing the date of application of most Medical Devices Regulation (MDR) provisions to May 26, 2021. The final text of the regulation can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32020R0561&from=EN.

The postponement was approved unanimously and was considered unavoidable since the outbreak of the covid-19 pandemic in early 2020 made it very clear that businesses, notified bodies and regulators would not be ready in time for the entry into force of the MDR requirements in May 2020.

The European Commission noted, with some relief, that  “this postponement takes the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis” (https://ec.europa.eu/growth/sectors/medical-devices_nn).

While the postponement might have been triggered by the covid-19 pandemic, there is no doubt it now gives regulators and the industry alike the chance to remedy the delays that have accumulated over the past few years, with the hope that they will come prepared to the new deadline of May 2021.