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 :

Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context (631 KB)





Source : https://ec.europa.eu/docsroom/documents/40607







Featured Posts
Recent Posts
Archive
Search By Tags
Follow Us
  • Facebook Basic Square
  • Twitter Basic Square
  • Google+ Social Icon

© 2006 - 2020 by Baguette

Proudly created with wix.com