The Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 and (EU) 2017/746 regarding medical devices and in vitro diagnostic medical devices respectively, has been published in the Official Journal of the EU. The text introduces important changes regarding the use of the Eudamed database and imposes new obligations on manufacturers in the event of a supply interruption of devices.

Specifically, the Regulation amends provisions related to the use of Eudamed (the European database on medical devices), providing for the gradual implementation of the relevant modules (as soon as these have been verified and declared functional and the relevant notice has been published in the Official Journal of the EU), and introduces the obligation for manufacturers, in the event of interruption or cessation of supply of a medical device, to inform the competent authorities and healthcare professionals at least six months in advance, if it is reasonably foreseeable that such interruption or cessation of supply could cause serious harm or a risk of serious harm to patients or public health in one or more Member States.

Additionally, Regulation (EU) 2024/1860 extends the transition period for the application of Regulation (EU) 2017/746 based on the risk class of medical devices, in order to ensure patient safety and guarantee the continuity of supply of essential medical devices on the European market.

Regulation (EU) 2024/1860 was published in the Official Journal of the EU, Series L, on July 9, 2024, and came into force on July 29, 2024.