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
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.