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Liability of Authorised Representatives and Importers under the EU MDD

This article was originally published in RAJ Devices

Executive Summary

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 directive1. 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. In particular, it brings into focus far more clearly and comprehensively than was previously the case the role of the authorised representative in import transactions in the EU, in that it opens them up to potential liability to which they have never before been exposed.

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German Case Law & Recall Obligations

A recent verdict by Germany’s Federal High Court of Justice on the extent to which medical device companies are under obligation to remove defective products from circulation marks a milestone in German case law on the matter1.




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