Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts