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Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746)  This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745..

Introduction – Objectives of the MDR/IVDR amendment The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics: 1. Regulation (EU) 2024/1860 aims to ensure a high level of patient safety and public health protection, including the mitigation of risks related to discontinuation or interruption of supply of in vitro diagnostic medical devices (IVDs) needed fo..

In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety. Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. In 2023, the Commission took measures to ensure the availability of medical devices. Today, we ..