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European Union (EU) Medical Device Directive (MDD) Changes: Industry Impact Analysis
GlobalData, April 2010, Pages: 6
European Union (EU) Medical Device Directive (MDD) Changes: Industry Impact Analysis
Summary
Medical devices are primarily used for a physical effect on the body and are overseen by regulatory systems for the purposes of safety and efficacy. Manufacturers must receive commercial authorization to launch a product commercially. Compliance with requirements of the European Union’s (EU) Medical Device Directive (MDD) is shown by placing the CE marking on the marketed product and supplying the device with a declaration of conformity. A marked change has occurred in the European market due to a new Medical Device Directive (MDD) regulation which has come into effect from March 2010. In September 2007, a new medical device directive, 2007/47/EC, was approved which sets out to clarify and update the current Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMD). Whilst most changes in the new directive are clarifications of existing regulations, there will still be a significant impact on the medical device industry with it. Companies will need to adapt and conform to these new directives before the deadline or either risk facing a delay in achieving CE marking for their products or lose the certification on their current products.
Scope
The report provides insights into the new medical device directives issued by European Union. The scope of the report includes:
- Overview of Changes in EU medical device directive
- Impact of directive changes on the medical device market in Europe
Reasons to buy
The report will enhance your decision making capability in a more rapid and time sensitive manner. It will allow you to:
- Develop business strategies by understanding the changes in the medical device directive
- Design and develop your product development and regulatory processes based on the new changes in Europe
- Develop market-entry and market expansion strategies
- Make more informed business decisions from the insightful and in-depth analysis of the European Union medical devices market
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