All publications

Global GS1 Standards meet the European Commission’s criteria for the issuance of UDIs and will support the EU regulators in ensuring a successful implementation of the UDI system as defined by the EU Medical Device and In-Vitro Diagnostic Medical Devices regulations, and enabling manufacturers to comply with these requirements that enter into force in May 2020.

The UDI system intends to provide a globally harmonised framework for identification of medical devices to enhance quality of care, patient safety and business processes.

GS1 has been accredited as UDI issuing agency by the US FDA since 2013, and other regulators are also planning to allow the use of GS1 standards as the basis of their national UDI system.

Read the official announcement (pg. 73)

Please login or register to post comments

Recent posts

  • Visibility: The New Value Proposition for Health Systems (Condensed Version) +

    Up to 23,000 Canadians die in hospitals annually due to Read More
  • Webinar for Physician Leaders +

    This webinar was presented by the Canadian Society of Physician Read More
  • TCIF 2018 - Interview with Dr. Anne Snowdon +

    TCIF 2018 - INTERVIEW WITH DR ANNE SNOWDON ON WOMEN AND Read More
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
Join our network today

Sign up

SCAN Health Platforms