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

rthermore, the meaning of the CE mark should be reviewed since it is often interpreted as meaning that clinical effectiveness has been established.

  • Product standards should be developed for each category of medical device in class II and III (medium and high risk), with medical experts recommending specific standards for their clinical performance and effectiveness including requirements for follow-up studies.

  • Adequate transparency, with the content of dossiers prepared by companies when submitting their devices for approval being disclosed to physicians so that they can know the technical performances of the devices.

  • There was recognised to be a need to introduce comprehensive registries of devices and their outcomes, with every physician having a responsibility to report complications of devices.

    The EHJ paper highlighted the complexities of the current system of European medical device regulation which is the responsibility of the 27 member States of the European Union (EU), each of which has its own national "competent authority". Unlike the EMA, established in 1995, where companies can submit a single application for authorisation by the European Commission (EC) and marketing throughout Europe, there is no single, common European agency for assessing devices, and the main role of the EC is purely advisory.

    Devices are assigned to four groups according to their perceived risk before they are approved low-risk cardiovascular devices in Class I ( such as stethoscopes), IIa (which includes devices for monitoring blood pressure and diagnostic equipment), IIb (which includes diagnostic radiology equipment such as X-ray machines) and Class III (which includes implantable devices such as coronary stents , prosthetic heart valves and defibrillators). Any manufacturer wishing to obtain approval to market a new device in classes IIa, IIb or III must undergo a conformity assessment procedure by one of the
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  • Contact: Jacqueline Partarrieu
    press@escardio.org
    33-492-947-756
    European Society of Cardiology
    Source:Eurekalert

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