1WorldSync for Unique Device Identification Compliance

 

A Seamless and Proven Process

Our experts will help identify and create a sustainable process to successfully publish UDI compliant product information to the Global Unique Device Identification Database (GUDID).  Best of all, our direct integration with the GUDID eliminates the need for your business to build a dedicated pipe.

We understand that the product information you're sharing resides in multiple places, formats and systems, and is even controlled by different functions. That's why we provide a seamless and proven process to collect, store, manage, and distribute product information, whether it's for your customers, trading partners or for compliance with the UDI regulation.

Advanced Readiness

With the 1WorldSync UDI Solution your business can prepare and validate medical device product information before the compliance deadline, giving you more time to focus on producing the quality products your customers and patients love. 


Key Compliance Deadlines

24 September 2014 Class III

The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. Data for these devices must be submitted to the GUDID database.
25 September 2015

Class II b

The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database

24 September 2016 Class II a

The labels and packages of class II medical devices must bear a UDI. Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.
24 September 2020 Class I

The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database.

 

 


1WorldSync helped streamline our internal processes and create a single source of truth, ensuring we had the accurate and complete product information in time for the Class III UDI compliance deadline. This scalable model is currently working to prepare 8,000 products for Class II and over 10,000 products for Class I. 

- Holger Clobes, B. Braun