Coding and Traceability Solutions with UDI (Unique Device Identification)
UDI Implementation for Medical Devices according to EU MDR 2017/745
UDI (Unique Device Identification) is the unique identification system for medical devices introduced by EU Regulation 2017/745 (MDR) for medical devices and Regulation 2017/746 (IVDR) for in vitro diagnostic devices. Every medical device entering the European market must bear the UDI in human-readable format and in automatic format via DataMatrix or RFID, with registration in the European EUDAMED database. The UDI consists of a fixed Device Identifier (DI) and a variable Production Identifier (PI) which includes lot, serial number, and manufacturing date. Explore Data Matrix solutions.
UDI-compliant Marking Systems and EUDAMED Integration
Correct UDI implementation requires marking technology capable of ensuring the DataMatrix quality demanded by ISO/IEC 15415, as well as integration with company information systems for the generation and registration of Production Identifiers. The marking system must be validated according to GAMP5 principles with IQ/OQ/PQ documentation. The registration of each UDI in the EUDAMED database is carried out via the device manufacturer's IT system. Incorrect UDI implementation can block the commercialization of the device on the European market. Contact our technical consulting team for support with UDI implementation.
