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Border line products?

Updated: Jun 15, 2023

#Manual on #borderline and #classification for #medicaldevices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

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 manual will provide guidance on the borderline products to determine if they are Medical Devices, In Vitro Diagnostics or other.

Download the copy here:

Download PDF • 722KB
Border line products
Border line analysis

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