Module 19 2021

01/06/2021

UDI

• 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

IVDeology Ltd | www.ivdeology.co.uk

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01/06/2021

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UDI components and format

• 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)

IVDeology Ltd | www.ivdeology.co.uk

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01/06/2021

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