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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

EU advisement committee: European Commission may create a "high-level consultative committee" on devices, Irish Medicines Board Medical Devices Director Ann O'Connor reports at AdvaMed's international conference in Washington, D.C. Oct. 27-28. The committee would clarify proper device classification, which, O'Connor warns, is imperative under the pharmaceutical legislation review, enacted in March. "One of the key points from the medical devices side is that if you're not sure how to classify your product, by default, the product could end up under pharmaceutical legislation." Device industry reps and regulators met Oct. 28 "to look at the implications of the pharmaceutical legislation strictly from our point of view," she says, noting combo products are most likely to suffer confusion....EC report: Pharma and devices competitiveness study likely will be released in December, according to O'Connor. The study, which is being monitored by a joint steering group comprising EU member state reps and industry, includes analyses on the impact of devices on healthcare and public expenditure, innovativeness and strategy, and information on economic performance...

Electronic Labeling: Globally Harmonized Policy On The Horizon?

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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