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Authorized Representatives Medical device manufacturers may rely on their authorized representati

Authorized Representatives


Medical device manufacturers may rely on their authorized representatives in the European Union to meet some of these pending requirements. While ensuring EEE compliance and preparation of technical documentation must be addressed solely by manufacturers, authorized representatives may be mandated to maintain Declaration of Conformity and technical documentation on file for 10-year periods; provide product and Declaration of Conformity information to competent national authorities upon request; and cooperate with national authorities in any effort to ensure RoHS compliance on behalf of manufacturers they represent.


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