,"The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device Coordination Group, published Version 4 of its Borderline and Classification Manual. The document compiles agreements reached among Member State competent authorities under the Helsinki Procedure on the interpretation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The Manual addresses borderline cases—where it is unclear whether a product qualifies as a medical device, IVD, or another category—and provides guidance on classification across different risk classes.
While the Manual serves as an important reference tool for regulators and stakeholders, it is not legally binding and does not represent the official position of the European Commission. Final decisions remain with national competent authorities and courts. The Manual aims to support consistent application of EU legislation, reduce divergent interpretations that could affect public health and the internal market, and facilitate dialogue among regulators, with stakeholder input as observers."