01. November 2018

Update of the Borderline Products Guidance issued by the EU-Commission introducing 5 new borderline products.

07. December 2017

The Borderline Working group chaired by the EU Commission published the updated Version 1.18 of the "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES". The document is intended to act as a guidance for the interpretation of the MDD and IVD. The new paragraphs introduced by the update are identified by the pictogram "New" and include the products: Products intended to reduce the effect of alcohol Radiation shields D-mannose for the prevention of...