The scale has tipped. After holding out for months facing calls from industry and some Member States, the Commission finally gave in to the COVID-19 health crisis argument. On Friday 3 April, it published a Regulation delaying the implementation of the rules on medical devices. However, the Commission claims that this does not affect the rules on in vitro medical devices.
“A shortage of key certified medical devices or delays in bringing them to market would not be tolerable in the current situation. The Commission is therefore taking a pragmatic approach and delaying the entry into force of new EU rules on medical devices”, justified Vice-President for Promoting our European Way of Life, Margaritis Schinas.
The document therefore adapts Regulation 2017/745 on medical devices, adopted 3 years ago, with regard to the pandemic (see EUROPE 12454/22). It is noted in the text that the pandemic has a significant impact on various equipment covered by the Regulation on medical devices, such as medical gloves, surgical masks, intensive care equipment and other medical equipment. And to conclude that it is therefore very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure its proper implementation and application from the date of application initially foreseen, 26 May 2020. The new deadline for implementation is therefore extended to 26 May 2021.
A postponement welcomed by the medical devices lobby, MedTech Europe, which regrets, however, that the same treatment is not applied to in vitro diagnostic medical devices, which is due to be implemented on 26 May 2022.
At the Health Council on 14 June 2019, several Member States, led by Germany and Ireland, called for such a postponement (see EUROPE 12290/5). Link to the text of the Regulation: https://bit.ly/2XdfMg2 (Original version in French by Sophie Petitjean)