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EMEA TO PLAY A BIGGER ROLE IN REGULATORY DEVELOPMENT PROCESSES
JMDR: Future Revision of the European Medical Devices Directives

London, 8 July 2008 In its upcoming August 2008 issue, the Journal of Medical Device Regulation (JMDR) will publish an article entitled "Future Revision of the European Medical Devices Directives", written by Dr David Jefferys, a member of the JMDR's Editorial Advisory Board and Head of Global Regulatory, Senior Vice President, Eisai Europe Ltd, London, UK.

In May 2008, the European Commission launched a public consultation on its proposals for recasting (in a Regulation) Directive 90/385/EEC (on implantable medical devices), Directive 93/42/EEC (general framework) and Directives 2000/70/EC and 2001/104/EC (on blood derivatives). Dr David Jefferys examines the details of this questionnaire, which he believes clearly reveals the current thinking within the Commission and suggests a high involvement of the European Medicines Agency (EMEA) in future regulatory developments.

"This is the right time to pose these questions and the Commission should be congratulated on grasping the opportunity, especially as they are looking to 'future proof' the legislation to address the rapid developments in medical technology. Those who have been involved in Europe for many years and have studied the evolution of regulatory systems within the pharmaceutical sector, and more recently the devices sector, can see a clear trend. It has always been inevitable that the EMEA would become increasingly involved in the medical devices sector, not least because the products and the industries are becoming much closer", says Jefferys.

About the Journal of Medical Device Regulation

The Journal of Medical Device Regulation is intended to educate, provide professional guidance, develop core competence of regulatory professionals, and promote debate on fundamental and topical matters within the medical device industry. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the news headlines from around the world and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only publication which is currently only available in electronic format. Full articles are only accessible to subscribers of the JMDR.

For Further Information

For more information on the Journal of Medical Device Regulation please contact Marija Capek at Global Regulatory Press (tel: +49 (0)621 166 23 26) or visit the Global Regulatory Press website at www.globalregulatorypress.com.

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