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EUCOMED (European Confederation of Medical Device Suppliers Association) human tissue directive by mid-2001:

This article was originally published in Clinica

Executive Summary

A task force at the European medical device association, EUCOMED, aims to present firm proposals for a directive on devices incorporating human tissues by the middle of next year. The group, which met on November 29, does not believe that such products should fall under the medicinal products regime, except where the primary mode of action is clearly intended to be pharmacological. EUCOMED continues to believe that this legislation should be based on a risk/benefit approach with the level of control commensurate with the risk, and that it should cover sourcing, procurement and ethical issues, as well as manufacturing and aspects relating to its placing on the market.

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