Module 16 2022

9/2/2022

UDI Requirements (Article 27 and Annex VI)

UDI will be first time applicable in European Union with MDR : • A new database under the European regulation shall be installed • The UDI and product related information need to be uploaded into that database before placing a product onto the European market • Traceability is based only on UDI information in Eudamed database and transferred to Economic operators (Distributor, Authorized Rep, Importer etc.) • Details of product related information necessary for the upload are described in Annex VI, Part A and B • The UDI must be assigned by the manufacturer only!

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9/2/2022

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Eudamed and legacy devices Registration Do the legacy devices have the same identifiers as Regulation devices?

Legacy devices will not have a previously assigned Basic UDI-DI, they will be assigned a “EUDAMED-DI” in EUDAMED to ensure consistent handling of device registration in EUDAMED.

The EUDAMED ID concept?

The EUDAMED ID corresponds to the UDI-DI. The EUDAMED ID is a virtual Device Identifier. It exists in order to keep the structure and format homogeneous for the registration of Devices in EUDAMED. It is not applied on labels.

How is it issued?

In case the legacy device already has an assigned a UDI-DI, the EUDAMED ID is entirely generated by EUDAMED. In case the legacy device has not been assigned a UDI-DI, the DI part of the code can be partly assigned by the manufacturer. EUDAMED is considered as the “issuing entity” of the EUDAMED ID.

Source: https://eu-udi.zendesk.com/hc/en-150/articles/360019389377-What-about-Legacy-devices

The Organisation for Professionals in Regulatory Affairs

9/2/2022

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