The European Commission has published a Q&A document clarifying the requirements under Article 10a of the MDR/IVDR, introduced by Regulation (EU) 2024/1860. Effective January 10, 2025, the provisions mandate that manufacturers notify relevant authorities, economic operators, and health institutions about anticipated supply interruptions or discontinuations of certain medical devices and in vitro diagnostic devices.
Manufacturers are required to provide this notification at least six months in advance if the supply issue could result in serious harm or risks to patients or public health. In exceptional cases, such as unforeseen disruptions, the notification must be issued without undue delay.
To facilitate compliance, the Medical Device Coordination Group (MDCG) has published, with MDCG 2024-16, a Manufacturer Information Form. This form outlines the specific data manufacturers need to provide when notifying competent authorities about supply interruptions or discontinuations. Using this standardized form will help streamline the notification process and ensure all necessary details are captured.
Manufacturers should promptly review their portfolios and establish reliable processes to monitor and report planned and unplanned supply disruptions. Evaluating the potential impact of product discontinuations and ensuring timely communication with stakeholders is critical.
We are here to support you in identifying whether your products are affected and in adapting your processes to ensure compliance. Contact us today to secure compliance and protect patient safety.
