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What medical device manufacturers will have to observe in the future

Munich. Changed statutory requirements will apply to medical devices in the future. From 21 March 2010 on, the requirements of European Directive 2007/47/EC will apply throughout the European Union. No transitional period is planned. Because uncertainty still prevails concerning the implementation of the new regulations, TÜV SÜD is organizing a road show to inform about the content and consequences of the Directive. The road show will be launched on 25 September in Mirandola (Italy), further stations being Frankfurt/Main (30 October), Berlin (4 November) and Munich (12 November).

The requirements of the European Directive 2007/47/EC significantly expand the scope of the statutory provisions for medical devices. "Content-wise, requirements range from basic issues concerning classification and product categorization, for example, to the review and monitoring of technical documentation by the Notified Bodies", says Dieter Eckert, Head of Medical & Health Services of TÜV SÜD Product Service GmbH. In the wake of the legal reform, manufacturers may have to revise their conformity assessment procedures both for active implantable medical devices (90/385/EC) and medical devices (93/42/EEC), and may have to initiate appropriate re-assessment. "So far, our experience has shown that many of the companies affected are not yet clearly aware of the impacts of the new Directive and do not yet know how to implement the requirements within the stipulated deadlines", states Eckert. "Our road show therefore aims at casting some light on these issues and answering the most important questions directly."

Lecturers from industry associations, competent authorities and Notified Bodies will inform road show attendees at the four venues about the changes included in the new directive, which requirements must be implemented and by what date, the changes in TÜV SÜD audits and any further legal amendments to be expected in the medical devices sector in the future. The attendance fee for the road show is € 178.50 (including VAT) for TÜV SÜD customers and € 238.00 (including VAT) for non-customers. Registration can be made online at www.tuev-sued.de/New_MDD