Update to the Borderline Manual provides both guidance on product classification and insight into the Working Group thought process.

The European Commission has published an updated version of the Manual on Borderline and Classification for Medical Devices, commonly referred to as the Borderline Manual.

There are six new additions to the Manual, four of which relate to products which the Working Group concludes are not appropriate for classification as a medical device. The route by which the Working Group came to its conclusion concerning the appropriate