is being presented by Mika Reinikainen, Managing Director, with Abnovo Ltd. and airs on Tuesday, May 10th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Medical device companies wishing to market their products in the European Union must first determine the classification of their devices in accordance with rules set out in Annex IX of Council Directive 93/42/EEC. Device classification is based on the level of risk, from Class I (low risk) to Class III (high risk), and while manufacturers can self-certify certain low-risk devices, those posing a higher risk to users must have their classification verified by a Notified Body. This tiered system can lead to confusion, as device companies attempt to classify a wide variety of products.
This audio conference provides a detailed overview of the EU medical device classification system, and provides an update on the latest developments. The presentation reviews the various classes and categories, exploring the reasons and basic concepts behind them, and what they mean in terms of compliance. Using practical examples from industry, our speaker also discusses the emerging issue of classifying medical device software, as well as special devices and reclassification.
