Unique Device Identifier (UDI)
A UDI (Unique Device Identifier) is a unique identification code for medical devices. It is important for compliance with the Medical Device Regulation (MDR). GS1 is an accredited organisation for assigning these codes.
EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
MDR and IVDR require unique device identification of medical devices. Discover how GS1 helps you comply with these regulations.
US legislation Food and Drug Administration (FDA)
On 17 December 2013, the US Food and Drug Administration (FDA) accredited GS1 as a UDI Approved Agency.
The US FDA introduced this regulation in September 2013 to create a global, unique system for the identification of all medical devices sold in the United States. The US FDA wants to ensure patient safety and better protect the supply chain in the healthcare sector with this regulation.
The US FDA introduced this regulation in September 2013 to create a global, unique system for the identification of all medical devices sold in the United States. The US FDA wants to ensure patient safety and better protect the supply chain in the healthcare sector with this regulation.
Other Regulations for Medical Device Suppliers
The Public Policy Database provides the latest relevant regulatory requirements, stakeholder agreements and user requests related to healthcare product identification, product catalogues and traceability at the national, regional and local levels.
It contains information collected by the global network of more than 114 GS1 member organisations (MOs), members of the GS1 Healthcare global community, government bodies and regulators involved in healthcare.
It contains information collected by the global network of more than 114 GS1 member organisations (MOs), members of the GS1 Healthcare global community, government bodies and regulators involved in healthcare.
Hospitals and care institutions
Standardized healthcare in hospitals & healthcare institutions not only offers benefits for healthcare institutions, but also increases patient safety and efficiency in logistics.
The GS1 standards can contribute to a higher efficiency and thus safeguard the patient's rights. “The right dose of the right medication to the right person at the right time and in the right way.”
The GS1 standards can contribute to a higher efficiency and thus safeguard the patient's rights. “The right dose of the right medication to the right person at the right time and in the right way.”
Data exchange in the Healthcare sector
The healthcare sector is under constant pressure to provide high-quality care at lower costs. It is important to reduce errors and optimise processes. Exchanging correct and complete product data in a standardised manner certainly contributes to this.
My (pro forma) invoice
Here are the most frequently asked questions about invoicing at GS1 Belgium & Luxembourg. We hope you'll find the answer to your question here. If not, contact us and we will look into it together.