Module 16 2024

17/10/2024

Traceability

UDI is an enabler giving:

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• Supply Chain transparency

• Traceability of Medical Devices within the Supply Chain

• Increased security • Detection of counterfeits • Protection of brands • Automated order to cash processes • Mobile technology through apps • Empowering the consumer / patient • Authentication of products • Compliance

The Organisation for Professionals in Regulatory Affairs

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Traceability

• EUDAMED can aid traceability issues when it comes to identifying possible field safety issues and the whole scope of products which may be affected • The use of the Basic UDI-DI will enable the identification of all UDI-DIs and therefore all products within that group • It will also alert the Member States, NBs and CAs to the issues and solutions that are put in place • As there are more checks taking place by Economic Operators within the supply chain there is less likely to be any counterfeit product entering the supply chain

The Organisation for Professionals in Regulatory Affairs

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