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Update – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 – September 2025

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.

This document records the agreements reached by the Member State members of the Borderline and Classification Working Group following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

Read the news announcement published by Directorate-General for Health and Food Safety on 12 September 2025.

 


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (20 octobre 2025). Update – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 – September 2025. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/14zk6


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