GS1 Guidance on the UDI in EU - Alysidia

GS1 Healthcare is an open and neutral community. Its main aim is to bring all healthcare stakeholders together. This leads to the successful development and implementation of their global GS1 standards.

Overview of GS1 Guidelines

Core Purpose of GS1 Healthcare

The main purpose of GS1 Healthcare is to work on enhancing patient safety and increase efficiencies of occupational and supply chains.

Development and Implementation of GS1 Standard

Following experts usually participate in the development and implementation of GS1 standards

Benefits of GS1 Standards

GS1 standards regarding identification, data capture, and data sharing have always been beneficial for all of the stakeholders.

Members of GS1

Members of GS1 Healthcare include more than 100 leading healthcare organizations from all around the world.

GS1 & UDI in the USA

As an accredited issuing agency, GS1 has been functioning since 2013 to provide US FDA with UDI. Most of the medical devices are identified by GS1 identifiers all across the US.

Legal Requirements for UDI in Europe

GS1 Standards for UDI in EU

The EU regulations have brought forward a new identifier, the “Basic UDI-DI.” The UDI-DI allows medical device manufacturers to classify medical devices that have similar features in the EU regulatory database known as EUDAMED.

Assignment of UDI for the Medical Devices

As per EU MDR’s requirements:

• Medical device manufacturers or an authorized representative should perform the job of assigning UDI to medical devices.
• The assignment must be done out of normal trade item supply chain and
• The assignment must be done before submission of product for market registration to the competent authorities.

UDI in GS1 Terms

UDI Regulatory Requirements EU MDR & IVDR	GS1 Standards Product Identification
Basic UDI-DI The basic UDI-DI is the new level of identification for medical devices in the EU.	GMN (Global Model Number) The GMN of GS1 Standards does not contain any Application Identifier (AI) for regulated medical devices.
UDI-DI UDI-DI is abbreviated as Unique Device Identification-Device Identifier.	GTIN GTIN is abbreviated as Global Trade Identification Number.
UDI-PI The device shall be assigned a Production identifier (PI). This Production Identifier data will vary from the medical device to medical device, manufacturer to manufacturer, or current practice.	AI Application Identifier in HS1 Standards comprises the information regarding: Date of Expiration AI(17) – e.g. 26052019 Batch – lot AI(10) – e.g. 6441GF Serial Number AI(21) – E.G. 12345ABC
The UDI of regulated by EU MDR and IVDR comprises of UDI-DI (Unique Device Identification-Device Identifier) and UDI-PI (Production identifier). UDI= UDI-DI+UDI-PI	The UDI of GS1 Standards constitutes of GTIN (Global Trade Identification Number) and AI (Application Identifier).   UDI= GTIN+AI

Benefits of UDI Implementation

Implementation of UDI comes with many benefits such as

Reduction in Medical Errors

UDI makes reporting of adverse events easier, thereby preventing adversities associated with medical devices.

Effective Management of Medical Devices

Alysidia can help in Compliance of GS1 for UDI

Alysidia is an innovative solution provider for all EUDAMED and UDI requirements. It has a system and professionals who understand GS1 specifications as well. Let us know your queries through our Contact Us page.