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EU to apply rules in 2002 for devices using human substances

This article was originally published in Clinica

Executive Summary

Manufacturers of medical devices containing stable substances from human blood or plasma should be able to CE-mark their products for the first time by the end of next year. The European Parliament approved a draft directive on these substances on October 24. The Council of Ministers should adopt the document in November, with member states then having 18 months to apply the new EU requirements in their national laws.

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