Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of the authorities of the Member States where the product is on the market. However, when different interpretations of EU legislation occur, public health may be put at risk and the internal market distorted. As both are matters of concern to the Member States and the Commission, it essential to facilitate a dialogue among regulators. Appropriate participation of various stakeholders should also be ensured.
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…