EU UDI 服各台 信息汇总

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• 2023-3-22

Regulation (EU) 2017/745 on medical devicesEN••• and Regulation (EU) 2017/746 on in vitro diagnostic medical devicesEN••• introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.

UDI assignment

• Identifiers
• Packaging levels
• Issuing entities
• Obligations
• Unit of Use DI
• Legacy devices
• Software medical devices
• Rules for specific device types

UDI carrier

• Coding standards
• Deadlines
• Direct marking

Other relevant information

• Medical device classification
• EMDN codes
• Declaration of Conformity
• Quality management system

FAQ

• UDI assignment
• UDI carrier
• Other relevant information

Guidance documents

• MDCG endorsed documents and other guidance
• European Commission: Guidance documents
• Medical Device Coordination Group: Guidance on BASIC UDI-DI and changes to UDI-DI (PDF)
• European Commission: Public Health - Medical Devices - Unique Device Identifier

• User guides
• UDI Devices