| 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 |
EN – In 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.