Guidance on medical devices in Covid-19 context
The European Commission has published a guidance Q&A on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context.
Questions that are being addressed are:
- What is a medical device, active implantable medical device and an in vitro diagnostic medical device?
- What are the legal requirements for placing such medical devices on the EU market and how should the compliance with them be verified and documented?
- How can standards be used under the legislation?
- Where can standards be obtained?
- Due to the urgency caused by the COVID-19 outbreak, is there a possibility to derogate from the normal conformity assessment procedures?
- Is it necessary to register the devices?
- How can I get in touch with the national competent authorities?
- Off label use of a medical device
- Will the new Regulations on medical devices and in vitro diagnostic medical devices replace the three current Directives?
The document can be downloaded through this link.