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European e-labeling

This article was originally published in The Gray Sheet

Executive Summary

Eucomed submits proposal to EU Medical Devices Expert Group requesting that the EU alter its Medical Devices Directive to clarify that e-labeling may be used instead of paper labeling. The device trade association has been working to secure e-labeling in Europe, noting that the impending EU expansion will make the language requirements burdensome otherwise (1"The Gray Sheet" June 23, 2003, p. 6)...

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International Regulation In Brief

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Plans by the European Commission's Medical Device Experts Group to discuss electronic labeling during its imminent meeting signals the possibility of EU policy alignment with recently enacted U.S. legislation

Warning Letter Roundup & Recap – 26 January 2021

No device-related warning letters were released by the US FDA the week of 26 January.

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