The implementation of UDI will enhance patient safety and improve efficiency in the healthcare supply chain. The system is expected to unambiguously identify medical devices throughout the global supply chain by providing precise information to all healthcare professionals which will allow more accurate reports of adverse events, more effective management of medical device recalls and reduction of medical errors.
GS1 Standards are open, global, proven and simple. A global standardised system for unique identification and traceability is imperative to comply with the increasing legal requirements globally. GS1, since 2013, is an accredited issuing agency for the US FDA for the UDI (Unique Device Identification) Rule in the US. Currently most of the medical devices are identified with a GS1 identifier and GS1 MO’s across the world are supporting their users in the implementation. The EU Regulation on medical devices (“EU MDR”, 2017/745) and the EU Regulation on in-vitro diagnostic devices (“EU IVDR”, 2017/746) provide the legal requirements for the European Unique Device Identification (UDI) system within Europe. GS1 is also designated as an issuing entity for the UDI in the EU. More recently, Health Science Authority (HSA) had also announced its plan to implement UDI System in Singapore.
Find out how the role of GS1 Standards can help in UDI implementation.
From this webinar, you will:
- Learn the basics of GS1 Standards
- What is UDI?
- How to implement UDI with GS1 Standards
- Have a brief overview of UDI regulatory landscape
Who should attend?
Anyone who wants to learn how medical device identification can be improved with UDI implementation, in the pursuit of patient safety and efficient healthcare supply chain.