The European Commission has updated the manual on borderline and classification Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)(Version 5, April 2026) in April 2026 to include additional borderline and classification cases for specific products.
This document, hereafter called the Manual, records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR).
The purpose and operation of the Helsinki procedure is described in the dedicated document here. The BCWG is chaired by the European Commission and consists of representatives of competent authorities from all Member States with a number of stakeholder associations as observers.