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Recasting Legislation

When the European Commission published its public consultation document concerning the recast of the current EU provisions governing medical devices on 7th May 2008, this did not come as a great surprise to the informed public. In its ‘Communication to the European Parliament and the Council’ in 2005 on Implementing the Community Lisbon programme the Commission had already indicated its intention to recast two of the three basic EU Directives governing medical devices into a simplified regulation.

While the subsequent proposal may have been “much awaited” (as the Commission’s own press release claimed) it was not in the form of a regulation. Moreover, there was a certain level of disappointment that the proposal, as finally submitted, did not constitute the overhaul of the existing medical device legislation that was hoped for in at least some corners.

No explanation as to the change of legislative approach was provided in either the impact assessment report for the Commission’s proposal or in the explanatory memorandum that accompanied the proposal. Moreover, even before the resultant modifications to Directive 90/385/EEC (1) and Directive 93/42/EEC (2) had been adopted, there were already rumblings that it was time for a complete revision of EU medical device law. While the EU member states are still implementing the last set of amendments to the medical devices directives, and manufacturers continue to determine the likely impact of these for their products, the Commission is proposing a revision of this existing framework in order “to improve and strengthen the legal framework for the regulation of medical devices in Europe”.


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Elisabethann Wright has been practicing European law for more than 20 years. Her practice focuses largely on EU regulation of medical devices and pharmaceutical products. She has extensive experience in litigation before the European Court. Having successfully challenged decisions of the EU institutions before the European Courts, she also advises on EU law relating to government contracts.

Fabien Roy, a Legal Assistant in the Hogan & Hartson Brussels office, researches and assists in drafting legal opinions in the field of pharmaceutical law, and communicates regularly with the relevant authorities. He drafts reports on fields including: paediatrics, biosimilars, authorisation and control of pharmaceuticals, regulatory initiatives, oncology and diabetes. Fabien holds a degree of Public Law from the University of Silesia, and a Master’s Degree from the University of Rennes. Email: ewright@hhlaw.com

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Fabien Roy
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Elisabethann Wright
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