According to EU Regulation (EU) 2024/1860, May 28, 2026 will be a compliance threshold that all medical device enterprises must cross. Before that, they must complete the registration of EUDAMED-UDI / device modules; otherwise, their products will not be able to circulate in the EU market. The four core modules of EUDAMED (UDI, Devices, Notified Bodies, Vigilance) will be fully mandatory, covering the entire life cycle supervision of medical devices. For instrument and meter enterprises, especially manufacturers of in vitro diagnostic (IVD) devices, it is necessary to establish a quality management system compliant with the ISO 13485 standard to ensure the uniqueness and traceability of product identification. The EU has also issued a proposal to revise medical device regulations, simplifying regulatory processes, reducing the compliance burden on small and medium-sized enterprises, encouraging the application of innovative technologies, and opening up new market space for portable and home-use medical testing instruments.
Source: Sohu.com
