Press release

DEKRA tests and assesses mechanical ventilators during the COVID-19 pandemic

Jul 09, 2020
DEKRA laboratories in Arnhem (the Netherlands) and Malaga (Spain) are working on various projects of ventilator system manufactures. As these medical devices need to be assessed to assure its safety, the DEKRA teams are working hard to get it ready in the officially agreed accelerated timelines.
At the recommendation of the EU Commission (2020/403) dated March 13, 2020, the market supervisory authorities defined simplified processes for the market entry of medical devices. This accelerated process is designed to allow medical devices, which comply with the minimum basic requirements, to be approved for public use by the market supervisory authorities. The requirements for this accelerated process and minimum basic requirements are defined by the local governmental authorities.