The new European regulations on Medical devices and in vitro Medical devices were adopted on 05 April 2017 and came into force on 25th May 2017.
It must be stated that many notified bodies and companies provide insight and guidance on.
This short book (approx 120 pages) provides a foundation overview of the new regulations and how they are structured.
Both these 2 new regulations replace and repeal Council Directives 90/385/EEC, 93/42/EEC Directive 98/79/EC and Commission Decision 2010/227/EU.
The new European regulations on Medical devices and in vitro Medical devices were adopted on 05 April 2017 and came into force on 25th May 2017