Europe

Because medical devices such as medical gloves, surgical masks, intensive care equipment and other medical equipment play a crucial role within the context of the COVID-19 pandemic, the application date of various provisions of the European Regulation (Regulation 2017/745) on medical devices was postponed until 26 May 2021 (first scheduled for 26 May 2020).

This will give manufacturers, authorised representatives, notified bodies, distributors and importers of medical devices extra time to comply with the regulation.

Source: https://www.fagg-afmps.be/nl/news/uitstel_van_de_europese_verordening_voor_medische_hulpmiddelen_door_covid_19

https://www.knmp.nl/actueel/nieuws/nieuws-2020/igj-nieuwe-europese-verordening-medische-hulpmiddelen-jaar-uitgesteld

Share This