New European guidance on borderline products.

Publisher: Canon Communications Country of Publication: United States NLM ID: 9215490 Publication Model: Print Cited Medium: Print ISSN: 1048-6690 (Print) Linking ISSN: 10486690 NLM ISO Abbreviation: Med Device Technol

Publication: Los Angeles : Canon Communications
Original Publication: [Eugene, OR? : Aster Pub., c1990-

Government Regulation* ; Guidelines as Topic*; Device Approval/*legislation & jurisprudence ; Equipment and Supplies/*classification ; Equipment and Supplies/*standards ; European Union/*organization & administration ; Guideline Adherence/*legislation & jurisprudence

The European Commission has recently updated an important guidance document on determining whether or not a medical product is subject to medical device or medicinal product regulations. In addition, a new manual that provides practical examples has also been issued. This article discusses these documents.

Date Created: 20091027 Date Completed: 20091201 Latest Revision: 20091026

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