Medical Device Suppliers

The medical device industry is constantly evolving and facing more and more challenges.

Unique Device Identification (UDI) is a medical device identification system used by various global regulators.

With UDI, medical devices are uniquely identified, which increases patient safety and efficiency. This allows for better management of medical device recalls and reduces the risk of medical errors. 
The GS1 global standards comply with national and international UDI regulations and help manufacturers comply with European regulations, US FDA regulations and many other countries' regulations on UDI.

Medische hulpmiddelen
MDR

Unique Device Identification (UDI)

What is UDI? Which standards should be used?

 

Stappenplan

Steps plan

Follow our step-by-step guide to assigning UDIs to your medical devices.

Step 1

Overview of useful documents

Find all documents, legal texts and guidelines, articles, guides, local authorities and organizations in the healthcare sector

trainings

Follow our courses

GS1 offers a number of useful training courses to be aware of what everything should and may need

apps and tools

Apps and tools

Find here an overview of all useful applications and tools used in the healthcare sector

FAQ

FAQ

UDI is not easy. Find an answer to your questions

Which regulations do you fall under?

EU

EU Medical Device Regulation (MDR) & in-vitro diagnostics (IVDR)

UK

UK regulation National Health Services (NHS)

US

US regulation Food and Drug Administration (FDA)

wereld

Other regulations

Contact the sector helpdesk