Cardiologist Group Calls For Centralized Device Oversight In Europe

Article preview from "The Gray Sheet"- May 23, 2011

The European Society of Cardiology says medical device oversight in Europe is not sufficient, and is calling for a single European regulatory body to oversee product evaluation and approval.

Cardiologist Group Calls For Centralized Device Oversight In Europe

Article preview from "The Gray Sheet"- May 23, 2011

The European Society of Cardiology says medical device oversight in Europe is not sufficient, and is calling for a single European regulatory body to oversee product evaluation and approval.

The prominent cardiology group offered proposals for reforming European device oversight in an article published May 14 in the European Heart Journal.

The creation of a single regulatory authority for devices would be "the most efficient way" of providing uniform and higher standards for device reviews in Europe, the cardiologists write.

It could be either a division within the existing European Medicines Agency or an entirely new body.

The group presented some dozen recommendations, reached at a European Society of Cardiology policy conference January 27-28 that included experts from the European Commission, FDA, the American College of Cardiology and device industry trade groups.

Continued...

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