Theme Ventilators – Covid-19
Target Audience Manufacturers, Notified Bodies
Product concerned MD : Ventilators and their accessories
Regulatory reference MDR (EU) 2017/745

Article 59


MDD 93/42/EEC

Article 11(13)

Documents mentioned EN ISO/IEC 80601-2-12:2011 + Cor.:2011

EN ISO 80601-2-72:2015

EN 794-3:1998+A2:2009

EN ISO 80601-2-13:2012

European Commission : Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context


ENIn the context of the Covid-19, the demand for respirator-type devices has rapidly increased. This guide intends to outline the practical aspects of the different regulatory options for placing these devices on EU market indicating their feasibility to allow short-term supply and to avoid a possible shortage.