Understand the EU UDI system
On 5 May 2017, the new EU MDR 2017/745 and IVDR 2017/746 regulations were published and formally introduced the UDI system in the EU. One of the components of a UDI system is the UDI itself, which allows for the unambiguous identification of a specific device on the market and is composed of the UDI-DI and UDI-PI.
This white paper provides an overview of the EU UDI system, its requirements and the status of EUDAMED, along with some practical recommendations for manufacturers to support their UDI system compliance efforts.
Take advantage of our free medical device whitepapers
Our whitepapers will help you understand how to perform better, reduce risk and make excellence a habit in your organization. See below some examples of other available whitepapers.
- The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016
- EUDAMED: an overview of how it is being developed and deployed by the European Commission
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