Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

• IVDR states it will be based on international guidance

• Initial information on the acceptable formats appear to be the same e.g. GS1 and HIBIC • However, EU system will introduce Basic UDI-DI, not product specific but is for a group/family of products

• Information on required attributes not available yet

• This is not a finished item, need to keep an eye on developments

The Organisation for Professionals in Regulatory Affairs

13/04/2023

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• If the final pack of the product is a multi component kit then the final UDI level is that pack • If the final pack level is a box containing a number of the same items then the bag or box will have a UDI but then the individual items will have a UDI e.g. a bag of specimen collection kits

The Organisation for Professionals in Regulatory Affairs

13/04/2023

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