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 updated are identified by the Picture "New".
Important notice: This document is not applicable under the MDR unless further updates will integrate the reference to the (EU) 2017/745 or (EU) 2017/746.