Manual on Borderline and Classification for Medical Devices under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices

In December 2022 – the European Commission published version 2 of the manual on borderline and classification for medical devices.

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 (IVDR).

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