Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

• Unique Device Identification system (UDI system) based on international guidance

• Will be introduced through an implementing act

• UDI requirements completely new for EU market

• Intended to enhance effectiveness of Post Market safety activities

• UDI attributes to upload to Eudamed

• Phased introduction based on risk classification

The Organisation for Professionals in Regulatory Affairs

13/04/2023

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• UDI-DI - device identifier – specific to a manufacturer and device

• UDI-PI - production identifier – identifies unit of device production • The UDI must be present in both AIDC (automatic identification and data capture) and HRI (human readable interpretation) formats • Format for the AIDC UDI will be either linear barcode, data matrix 2D code or RFID (radio frequency identification)

The Organisation for Professionals in Regulatory Affairs

13/04/2023

18