Master Unique Device Identification (UDI-DI) for Highly Individualized Devices in the EU 👍

The EU Commission has today published A Delegated Regulation amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses.

🔹 EU Regulations 2017/745 introduced the Unique Device Identification (UDI) system for medical device traceability.

🔹 Highly individualized devices like contact lenses posed a challenge due to their numerous unique identifiers.

🔹 A "Master UDI-DI" concept was developed to group similar devices under one identifier, initially focusing on contact lenses.

🔹 The proposed regulation allows the Commission to establish a specific UDI-DI assignment rule for contact lenses, improving the UDI system's effectiveness.

🔹 The regulation will be effective 20 days post-publication and fully applicable two years after its entry into force, but manufacturers can assign a Master UDI-DI earlier.

🔗 Original Document:  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2023)4568