Team NB has published on its website a position paper about substantial changes impacting the device component of a drug device combination product under Article 117 of Medical Device Regulation (EU) 2017/745

According to Team-NB, the changes to the device components should be assessed in accordance with the principles applied to medical device substantial change assessments to confirm that the device component remains in compliance with Annex I of MDR (EU) 2017/745.

This document is intended to serve as a guide for determining the substantive nature of the proposed changes and thus to determine if a review by the notified body is needed.

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