Medical Device Regulation & In Vitro Device Regulation – Article 10a implementation – EU Commission Q&A published

Posted on 07.11.2024

The European Commission has published a Q&A on the obligation to inform about supply interruptions or discontinuations for specific devices, as required under Article 10a of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). This obligation, introduced by Regulation (EU) 2024/1860, affects manufacturers by mandating notification in cases of potential supply issues, beginning on 10 January 2025.

This amendment also addresses the gradual roll-out of the European Database on Medical Devices (EUDAMED) and includes transitional provisions for in vitro diagnostic devices. 

While this Q&A offers clarity on implementation, it leaves several anticipated challenges unaddressed, indicating the possibility of a future, updated version to address practical concerns. The guidance is part of ongoing efforts to ensure compliance and transparency in medical device availability. The full Q&A, with detailed information on Article 10a requirements, can be accessed here through the European Commission’s official publication, supporting manufacturers in adapting to these new obligations. 

For more information, please contact Carlos Pérez, Manager Medical Devices.