Medical Device Regulations – Article 10a implementation – EU Commission Q&A published

The European Commission has published a Q&A on the obligation to inform about supply interruptions or discontinuations for specific devices, as required under the new Article 10a of the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746). 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 Regulation also addresses the gradual roll-out of the European Database on Medical Devices (EUDAMED) and includes transitional provisions for in vitro diagnostic devices.

While the 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.