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FDA UDI vs. EU MDR Regulations - Consideration of the Regulations and Implications for EU Labeling

This paper explores the current FDA UDI regulation for medical devices and compares it to the upcoming EU MDR/IVDR regulation that will come into effect on 26 May, 2021. We examine the similarities and differences between the two regulations and the impact that the EU MDR regulation will have on regulatory labeling, outlining proactive steps for a smoother transition.

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Published in Journal for Clinical Studies Volume 13 | Issue 2 | 26 April 2021

Journal for Clinical Studies

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