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Device labeling symbols on EU-marketed devices need to be accompanied by explanation, exec advises.

This article was originally published in The Gray Sheet

Executive Summary

DEVICE LABELING SYMBOLS ON EU-MARKETED DEVICES need to be accompanied by explanatory text, Howard Dobbs, director of international regulatory affairs for Smith & Nephew North America, advised attendees at a June 4 session of the Medical Design and Manufacturing East conference in New York City. Dobbs said that symbols must be explained because the European Commission has not yet harmonized a European Standard for symbols. The issue is particularly problematic in light of the June 14, 1998 implementation date for the EU's Medical Devices Directive (MDD). Compliance with the directive has been optional since January 1995 ("The Gray Sheet" July 17, 1995, p. 20).

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