Module 16 2022

05/09/2022

Unique Device Identification

• Unique Device Identification – Current & Developing Legislation • US – already in place • EU – from 2021 – 2025 depending on risk Class • China – from October 2020 • Hong Kong - 2019 – 2022 depending on risk Class • South Korea – 2019 – 2022 depending on risk Class • Saudi Arabia – 2020 • Brazil – 2020 for high risk devices • Egypt – October 2022 • ANZ – database available now as test system, live voluntarily 2023, mandatory 2024 • UK, Japan, Taiwan, India, Singapore, Canada and Switzerland all tbc.

The Organisation for Professionals in Regulatory Affairs

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Unique Device Identification (UDI) – What is it?

• UDI is a two part system which can be used to identify a Medical Device at any given point in time within the Healthcare supply chain. • The first part of the system is a two part number: • A UDI-DI (Device Identifier) – this is a unique alphanumeric code allocated to a medical device at each packaging level. • A UDI-PI (Production Identifier) this will be the control method used in manufacturing: • Expiry Date or Date of Manufacture • Lot/batch number • Serial Number • DI + PI = UDI

The Organisation for Professionals in Regulatory Affairs

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