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  • Title: New European guidance on borderline products.
    Author: Donawa ME, European Commission.
    Journal: Med Device Technol; 2009 Sep; 20(5):22, 24-5. PubMed ID: 19852178.
    Abstract:
    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.
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