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International Regulation In Brief

This article was originally published in The Gray Sheet

Executive Summary

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...

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