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ESC Policy Conference makes recommendations for new EU medical device legislation
Date:5/16/2011

g new devices," said Professor Alan Fraser, who chaired the ESC Policy conference.

Taking the example of balloon angioplasty to illustrate the level of testing required, he said that manufacturers in Europe would only need to establish that the diameter of the artery is greater following the procedure or that a new balloon is equivalent to other balloons already on the market, and not that there had been any impact on clinical outcomes, such as mortality.

In Europe there are estimated to be around 200,000 different types of medical devices, produced by more than 11,000 companies, which employ more than half a million people and have combined annual sales of more than 72 billion.

The ESC Policy Conference - which was held at European Heart House January 27-28 2011 - was attended by around 50 delegates including experts from the five sub speciality organizations of the ESC, the American College of Cardiology, American Heart Association, the World Heart Federation, experts from the European Commission and the US Food & Drug Administration, and invited representatives from the device trade associations Eucomed and COCIR.

The delegates at the Policy conference called for:

  • A single co-ordinated European system to oversee the evaluation and approval of medical devices. This was felt to be the most efficient way of achieving integration and harmonization of processes between the competent authorities so that they apply uniform and higher standards. It could be organized as a medical devices division of the European Medicines Agency( EMA) or an entirely new body.

  • The Notified Bodies (NBs) should be reorganized as an integrated structure, with regulatory authorities directing applications for assessment of devices to appropriate specialist NBs. The NBs could become the technical division of a new European medical devices agency or could remain decentralized while operating within an integrated system. Fu
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Contact: Jacqueline Partarrieu
press@escardio.org
33-492-947-756
European Society of Cardiology
Source:Eurekalert

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