8 points on UDI for Medical Devices in the EU

8 Points on UDI for Medical Devices in the EU

📢 Based on the latest information, there are no specific dates for UDI implementation in the EU due to recent regulatory changes. However, we can say the following:

1. UDI assignment requirements became effective when the EU MDR and EU IVDR regulations became active (📅 May 26, 2021 for medical devices and May 26, 2022 for in vitro diagnostics).
2. Gradual implementation: The implementation of UDI is part of a gradual approach, with individual EUDAMED modules being implemented as they are declared functional. 🛠️
3. Voluntary use: The UDI module of EUDAMED is currently available for voluntary use. ✅
4. Mandatory assignment: Manufacturers must ensure that all devices and higher-level packaging are properly assigned a UDI. 📦🔗 
5. Storage requirements: Economic operators and health institutions must store UDI information, preferably by electronic means. 💾📂
6. Field safety notices: UDI must be included in any field safety notice for reporting serious incidents and field safety corrective actions. ⚠️📋
7. Integration in QMS: Manufacturers should integrate UDI considerations into their quality management systems, including design and development, production and process controls, and purchasing controls. 📐⚙️
8. Data maintenance: Companies should establish processes to verify that device information submitted to EUDAMED is kept updated to ensure ongoing compliance with MDR and IVDR requirements. 🔄🗂️

🕒 While specific implementation dates are not currently set, manufacturers should continue to prepare for UDI compliance and monitor for updates from regulatory authorities.

💡 Hamada consultants can provide you with the adequate support to navigate this UDI implementation.