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.
Showing posts with label Mika Reinikainen. Show all posts
Showing posts with label Mika Reinikainen. Show all posts
Monday, May 2, 2011
Thursday, October 16, 2008
The New Europe: Overview for Device Manufacturers
The new 25-member European Union has its roots in World War II and the Cold War. It is a collection of 25 very different markets in terms of size and development.
Although European law and policy attempts to create a huge single market of more than 450 million people, in reality much of that market is still highly segmented. The legacy of Communism still weighs heavy in most of the new members that joined in 2004, affecting the ability of Western medical device manufacturers to do business and deal with regulatory issues in these countries.
The New Europe: Overview for Device Manufacturers was presented by Mika Reinikainen, VP, of Quintiles Consulting on 2004-09-16. For more information, or to download this product, please visit our site www.fxconferences.com
Although European law and policy attempts to create a huge single market of more than 450 million people, in reality much of that market is still highly segmented. The legacy of Communism still weighs heavy in most of the new members that joined in 2004, affecting the ability of Western medical device manufacturers to do business and deal with regulatory issues in these countries.
The New Europe: Overview for Device Manufacturers was presented by Mika Reinikainen, VP, of Quintiles Consulting on 2004-09-16. For more information, or to download this product, please visit our site www.fxconferences.com
Subscribe to:
Posts (Atom)