• Alan Fraser

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    Email —  ******@***cardiff.ac.uk
    Professor of Cardiology Cardiff University, UK
    Chairman, Committee on Regulatory Affairs, European Society of Cardiology

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  • Prof. Alan Fraser

    Medical Devices and Evidence-Based Clinical Practice

    • 25/08/2016

    Time To Deliver The European Commission’s ‘New Approach’ The current system for evaluating and approving new medical devices within the European Union derives from the “New Approach” first proposed by the European Commission in 1985. That legislation was designed to harmonise all industry sectors in Europe, by delegating to independent “Notified Bodies” the responsibility to confirm that new...


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