When must an ending or interruption in the marketing of medical and in vitro diagnostic devices be notified? The European Commission recently published a decision tree to support the economic operators concerned.
The European Commission recently published a decision tree relating to Article 10a of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). When is it necessary to notify the ending or the interruption of the marketing of medical and in vitro diagnostic devices?
The decision tree is intended as a tool to help economic operators (mainly manufacturers and
agents) to determine in which cases a notification to the Federal Agency for Medicines and Health Products (FAMHP) is required in the event of ending or interruption of the marketing of medical devices and medical devices for in vitro diagnostic.
More information
Decision tree - Article 10a
Notification of ending or interruption of the supply of medical devices
Unavailability of health products - medical devices