The European Commission's guide on medical devices in the Covid-19 context
The European Commission published on April 3rd, 2020 a guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context.
After recounting definitions of MD, AIMD and IVDMD, this document reminds about the legal requirements for placing those devices on the European market, as well as ways to verify and document their compliance. In addition, the European Commission's guide provides a detailed list of harmonised standards in the context of the Covid-19 crisis as well as the possibilities to derogate from normal conformity assessment procedures because of the urgency created by the Covid-19 outbreak.
Download the complete guide here :
Source : https://ec.europa.eu/docsroom/documents/40607