UDI Certificate Types

Every medical device sold in Europe requires a valid approval certificate in accordance with MDR 2017/745 and IVDR 2017/746. It certifies that the product meets all regulatory requirements of a medical device. By combining a product group into a Basic UDI-DI, only one certificate is required for a product group instead of for each item within a product group. The certificate type specifies the type of the product certificate associated with the device.

UDI certificate types are currently not relevant for the FDA.

UDI Certificate Types

Field Description
Code Specifies a certificate type code that you can select.
Description Specifies a text to describe the certificate type.
EU Certificate Type Specifies the certificate type that will be used when exporting to EUDAMED.

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