Devices & Diagnostics Community

Topic: EU Borderline Device Classification Manual Updated 

1.  EU Borderline Device Classification Manual Updated

Posted 3 days ago
Hi All,

In case this is of interest to anyone, the European Commission has published an update to the Manual on "Borderline and Classification in the Community Regulatory Framework for Medical Devices", making this version 1.18.

The 82-page manual is intended as a tool for the case by case application of community legislation by the member states and is not legally binding.

More info on Borderline Products is listed under the Medical Devices page of the European Commission.

Thanks and have a lovely weekend!

Kristiina Rosin
Reg.Policy&Intelligence Manager
Abbvie LTD.