Europe – 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 (Revised)

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…