New rules for medical devices and in vitro diagnostic devices

On July 9, 2024, Regulation (EU) 2024/1860 was published, aiming at introducing changes to the medical devices regulation and to the in vitro diagnostic devices regulation (“Medical Devices Regulations”), in what concerns potential situations of shortages of medical devices and of in vitro diagnostic medical devices.

As of the date of application of the Medical Devices Regulations, market operators have been given specific deadlines to proceed to the necessary adaptations to their medical devices and in vitro diagnostic medical devices and to obtain the updated certification from notified bodies appointed under the Medical Devices Regulations. These transitional steps would be essential to ensure that medical devices and in vitro diagnostic medical devices could continue to be marketed within the European Union.

In this context, European bodies have recognized that, despite the increase in the number of notified bodies appointed under the Medical Devices Regulations, the overall capacity of notified bodies is still not sufficient to ensure the certification of the large number of devices which are to undergo conformity assessment.

Therefore, the risk of shortages of medical devices and of in vitro diagnostic medical devices is particularly relevant nowadays, especially because of the transition from the Medical Devices Directives to the Medical Devices Regulations.

Given this context, Regulation (EU) 2024/1860 has been approved to introduce measures to contain and control shortages of medical devices and of in vitro diagnostic medical devices, thus amending the Medical Devices Regulations. These measures cover medical devices and in vitro diagnostic medical devices, including devices placed on the market under the transitional periods, and essentially consist of the following:

• New obligations to manufacturers: in case of interruption or discontinuation of the supply of certain devices, if it is reasonably foreseeable that such interruption or discontinuation could result in serious harm or a risk of series harm to patients or public health, manufacturers shall (i) inform competent authorities of the Member States, as well as (ii) economic operators, health institutions and healthcare professionals to whom they directly supply the devices.

The information shall be provided by manufacturers at least 6 months before the interruption or discontinuation and, in the communication with competent authorities of Members States, be accompanied by the reasons which justify the interruption or discontinuation.

• New obligations to economic operators (other than manufacturers): economic operators, such as importers, distributors, who are informed of interruptions or discontinuations shall inform any other economic operators, health institutions and healthcare professions to whom they directly supply the device.

The information shall be provided by economic operators without undue delay.

Further to the above and with the same purpose of containing shortages of in vitro diagnostic medical devices, Regulation (EU) no. 2024/1860 also introduced new transitional periods for these devices. Similarly to what had already been foreseen in the Medical Devices Regulation, these new rules allow market operators to continue to place on the market in vitro diagnostic devices which already have their conformity assessment certificates expired (but not withdrawn), under certain conditions, until the following deadlines:

• Class D devices (high risk): until December 31, 2027;
• Class C devices (moderate to high risk): until December 31, 2028;
• Class B devices (low risk): until December 31, 2029.

Through this Regulation, European bodies have also taken the opportunity to regulate the gradual roll-out of EUDAMED. In this context, it is now clear that market operators will be required to use EUDAMED as of the beginning of 2026.