Lifting the Veil of Uncertainty: UDIs for Medical Devices
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Lifting the Veil of Uncertainty: UDIs for Medical Devices
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The FDA Final Rule on UDIs (unique device identifiers) for medical devices is expected to be published in early August. In May the EU Commission announced their intention to take an internationally harmonised approach and follow the FDA's decision over here in Europe. In this exclusive interview Inge Ørnhøj, Senior Process Improvement Manager, Supply Chain Process Improvement at Coloplast A/S, speaks to Andrea Charles from Pharma IQ, about the impact she thinks the regulation will have on the industry and the main challenge facing UDI labelling over the next 1-3 years. Ørnhøj also shares lessons learnt from implementing a UDI labeling project and her future predictions with regards to unique identifiers for medical devices.
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Inge Ørnhøj
FDA
UDI
medical devices
traceability
unique identifiers
UDI labelling
supply chain medical devices
unique device identifier
FDA UDI proposal
