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

Sophia Antipolis, France, Sunday 15 May 2011: The European Society of Cardiology (ESC) is calling for a single, co-ordinated European system to oversee the evaluation and approval of medical devices. The call is being made in a paper published online in the European Heart Journal reporting on a conference held by the ESC in January 2011 looking to increase the input of medical experts in developing medical device policy.

"The ESC believes that the approval of devices used in medicine shares similarities in terms of ethical responsibilities as the approval of new drugs," said Professor Michel Komajda, the President of the ESC, who was one of the authors of the paper. As the European Union is currently engaging in the revision of the current regulation system of medical devices, he added, it was felt an "opportune time" for the cardiology community to share their expertise and views from the clinical and academic perspective. The current system for testing and approving devices in Europe was established more than 20 years ago, and concerns have been raised that it should adapt to technological advances and changing patterns of medical practice.

The policy conference highlighted the system that currently operates in Europe where the manufacturers of medical devices must satisfy the relevant "essential requirements" of safety and performance but do not need to establish that their device has an impact on clinical outcomes, even if it is a completely new technology. Instead, unlike the manufacturers of pharmaceutical agents , the manufacturers of medical devices are allowed to use surrogate or functional endpoints in studies.

"Standards of testing of medical devices are less rigorous in Europe than the US, where they have to undertake trials to show that the device has an impact on clinical outcomes, with the reality that European patients are currently exposed to an unfair proportion of the risks associated with developin
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Contact: Jacqueline Partarrieu
press@escardio.org
33-492-947-756
European Society of Cardiology
Source:Eurekalert

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