Complying with UDI Part 2 – Basics UDI-DI
Complying with UDI | Part 2 – Basic UDI-DI
You will learn about the Basic UDI-DI and what it is used for (webinar in English).
In contrast to the USA, Europe requires the Basic UDI-DI, on top of the UDI Device Identifier (UDI-DI) and the UDI Production Identifier (UDI-PI). This webinar will explain what it is used for and how it is defined. You will learn how to use it for product registration and what attributes are recorded in the EUDAMED.
This webinar is one of a four-part series
- Complying with UDI | Part 1 – Fundamentals
- Complying with UDI | Part 2 – Basic UDI-DI
- Complying with UDI | Part 3 – Labeling in accordance with MDR Art. 2, 12
- Complying with UDI | Part 4 – EUDAMED and its modules according to MDR Art. 33 and 34
The webinar also talks about the use of GS1 standards in association with UDI. However, these standards will not be addressed in detail. Further information about GS1 standards and their use can be found in the webinar Implementing UDI with GS1 standards or in the seminar Get ready for UDI! Fulfilling UDI requirements using GS1 standards.
At the end of this webinar, you will know what the Basic UDI-DI is used for, how it is registered and what attributes it includes.
Managers and specialists in the fields of
- quality assurance,
- IT or export,
who are working for manufacturers of medical devices and technology and who are involved in the implementation of UDI requirements.
About Jay Crowley
Jay Crowley is currently Vice President, UDI Solutions and Services, at USDM Life Sciences. Prior to joining the firm in January 2014, Crowley was Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He held a variety of positions over his nearly 27 years at FDA. Jay had primary responsibility for the development and implementation of FDA’s Unique Device Identification System and the development of the GHTF and IMDRF UDI guidance documents.