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EC updates guidance on devices with animal tissues

This article was originally published in Clinica

Executive Summary

The European Commission has published a final draft of a revised guidance document (meddev) on devices utilising tissues or derivatives originating from animals for which a TSE risk is suspected. The purpose of the guidance is to aid the common application of Commission Directive 2003/32/EC on devices containing animal tissues by clarifying some aspects of its interpretation. In particular, it addresses the evaluation performed by the notified body, the activities of the co-ordinating competent authority and the verification role of the other competent authorities. Meddev 2.11/1 revision 2 is dated January 2008, and is available at: http://ec.europa.eu/enterprise/ medical-devices/meddev/2-11-1-rev2-bsetse-january2008.pdf

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