The role of the authorised representative in the European Union has taken on a deeper significance as a result of the changes brought about by Directive 2007/47/EC, the medical device amending directive 1. The directive, which applies from 21 March 2010, will for the first time require non-EU based manufacturers selling products in the EU to have a single authorised representative within the EU to communicate with notified bodies and competent authorities on their behalf
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