UDI & Product Traceability for Medical Devices: White Paper

UDI & Product Traceability for Medical Devices: White Paper
PDF
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5 Pages
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8min

The obligation for UDI assignment applies from the date of application of the two new EU Medical Device Regulations: 26 May 2020 for medical devices and 26 May 2022 for In Vitro diagnostic medical devices.

In the following whitepaper, we explore the extent to which a more strategic approach to labeling digitalization can better serve the business, as well as industry regulators.

Quote from White Paper: "Interoperability will have a direct bearing on the end-to-end traceability of all label content. Harnessing a master file which contains the correct, approved source content means that throughout the organization and right along the supply chain it will be possible to trace back the types of labels, as used in all marketing anywhere, to the original single source - thereby giving complete global visibility and traceability."

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