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Medical Device Regulation

International News In Brief

This article was originally published in The Gray Sheet

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Executive Summary

The European Commission releases a final regulation detailing requirements for device manufacturers who wish to provide instructions for use in electronic form. EC also offers guidance on the regulatory status of stand-alone medical software. More international news.

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International News In Brief

U.K. identifies business benefits and costs related to electronic instructions for use. Australia launches public database of device adverse events. More international news.

International News In Brief

Comments sought on regulatory reform in Europe and harmonization in Asia. More news from around the globe.

International News In Brief

Congress passes U.S.-Korea Free Trade Agreement

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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