29.01.2024
To the attention of all stakeholders
Please be informed that on 23 January 2024, the European Commission published a proposal to rectify Regulation (EU) 2017/745, intended for medical devices (MDR) and Regulation (EU) 2017/746, intended for in vitro diagnostic medical devices (IVDR).
The proposal aims to:
– ensure the availability of in vitro diagnostic medical devices by giving manufacturers more time to adapt to the new rules, subject to certain important conditions;
– increase transparency and protect patient care by accelerating the launch of parts of the European database on medical devices – EUDAMED;
– to give healthcare systems more time to protect patient care, by requiring manufacturers to submit notifications, in the event of supply disruptions for certain medical devices and in vitro diagnostic medical devices.
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