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Purchase CD & CD-ROM of this audio conference
Both regulators and industry herald the Medical Device Directive 93/42/EEC (MDD) as a success in managing medical devices onto the European market. The CE Mark is now firmly established and globally recognized, facilitating the free movement of medical devices throughout the European Union. As foreseen in the MDD, Competent Authorities have spent the past two years considering the positives and negatives of the CE-Marking system: what has gone well and what should be improved. The MDD review is now reaching its climax and has included some radical and critical changes - from the way that Notified Bodies work, to the oversight by Competent Authorities, specific definitions within classification rules, and strengthening the requirements for clinical data including clinical investigations. In this presentation, Dr. Chignon describes how 93/42/EEC is changing and the likely impact this will have on the medical device industry. This audio conference will cover:
About the speaker: Dr. Thierry Chignon is a Principal Consultant with Quintiles Consulting Europe. He has over 15 years of regulatory affairs experience, working with many different products including medical devices. Thierry provides strategic advice and practical support for pan-European marketing and helps clients to solve issues related to the European National Authorities (including vigilance issues). Thierry has been working for more than five years as an Expert of the Commission of the European Union on medical device regulation. In particular, he has been preparing and negotiating on behalf of the Commission, Directive 2000/70/EC for inclusion of medical devices utilizing human blood derivatives, and has collaborated on the preparation and approval of Directive 2003/32/EC for TSE risk management and Directive 2004/23/EC on human tissue procurement/establishment. He is also an Expert for the French Agency for Health Care Products (AFSSaPS). Who should attend?
This audio conference is classified as General Interest.
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