Medical Devices

Unique Device Identification for Medical Devices

The EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR)have been adopted on 5 April 2017 and define the requirements for the EU UDI system.

GS1 standards are enabling healthcare manufacturers from around the world, to create and maintain UDI numbers by following the EU Regulations and the GS1 General Specifications. According to the Regulations, a UDI number must be applied to the medical device label, its packaging and, in some cases, the device itself.

GS1 Standards for UDI in the EU

In difference to the US FDA regulation, the EU regulations introduce a new identifier – the “Basic UDI-DI”. It allows to group medical devices with similar features within the EU regulatory database EUDAMED. It is assigned outside of the normal trade item supply chain. The assignment must be done by the medical devices manufacturer or authorised representative, before the product can be submitted for market registration/approval to the competent authorities.

Benefits

The implementation of UDI can enhance patient safety and improve efficiency in the healthcare supply chain. The system is expected to unambiguously identify medical devices throughout the global supply chain by providing precise information for healthcare professionals, thereby providing a secure global supply chain allowing for more accurate reports of adverse events, more effective management of medical device recalls and reduction of medical errors.