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    Eucomed Edma ghtf-5

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    The document discusses a meeting of the Global Harmonization Task Force (GHTF) where regulators and the medical technology and in vitro diagnostic industry committed to continued collaboration on developing consistent global regulatory systems. Representatives from the European Diagnostic Manufacturers Association (EDMA) and the European medical technology industry association (Eucomed) welcomed the outcomes of discussions around ensuring access to innovative medical technologies. Both EDMA and Eucomed will remain active partners in the future work of GHTF.

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    Eucomed Edma ghtf-5

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    The document discusses a meeting of the Global Harmonization Task Force (GHTF) where regulators and the medical technology and in vitro diagnostic industry committed to continued collaboration on developing consistent global regulatory systems. Representatives from the European Diagnostic Manufacturers Association (EDMA) and the European medical technology industry association (Eucomed) welcomed the outcomes of discussions around ensuring access to innovative medical technologies. Both EDMA and Eucomed will remain active partners in the future work of GHTF.

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    The document discusses a meeting of the Global Harmonization Task Force (GHTF) where regulators and the medical technology and in vitro diagnostic industry committed to continued collaboration on developing consistent global regulatory systems. Representatives from the European Diagnostic Manufacturers Association (EDMA) and the European medical technology industry association (Eucomed) welcomed the outcomes of discussions around ensuring access to innovative medical technologies. Both EDMA and Eucomed will remain active partners in the future work of GHTF.

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    Eucomed Edma ghtf-5

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    The document discusses a meeting of the Global Harmonization Task Force (GHTF) where regulators and the medical technology and in vitro diagnostic industry committed to continued collaboration on developing consistent global regulatory systems. Representatives from the European Diagnostic Manufacturers Association (EDMA) and the European medical technology industry association (Eucomed) welcomed the outcomes of discussions around ensuring access to innovative medical technologies. Both EDMA and Eucomed will remain active partners in the future work of GHTF.

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    PRESS RELEASE

    GHTF: Regulators, medical technology and in vitro


    diagnostic industry commit to future together
    Real opportunity for regulators and industry to participate in future forum
    Brussels, 16 May 2011 EDMA, the European Diagnostic Manufacturers Association, and Eucomed,
    the European medical technology industry association, welcome the outcomes of the constructive
    discussions that took place at the last GHTF Steering Committee meeting held on 11-13 May in
    Brisbane, Australia. Both regulators and industry have confirmed their commitment to continuing to
    collaborate on the development of robust, globally consistent regulatory systems which facilitate
    access to innovative, safe, effective and high quality, clinically beneficial medical technologies for the
    benefit of patients around the world.
    During the three-day summit, it became apparent that GHTF members appreciated the work of the GHTF
    Steering Committee over the past decades. There has also been a useful exchange of views on desirable
    elements of future forum. The Steering Committee also confirmed the review of the existing Study Group
    Works Plans and progressed on planned work. An overall consensus was reached on the necessity of
    enhancing international harmonisation, which was seen as a critical part in maintaining public health.
    Philippe Jacon, EDMA ad interim Director General, commented: I am particularly pleased with the outcomes of
    the GHTF Steering Committee as the planned work was taken further, and the support for existing GHTF
    guidance was reaffirmed.
    John Wilkinson, Eucomed Chief Executive, added: There is a real opportunity for regulators and industry to
    participate in the new direction this forum will take and I believe that all the members of the Steering Committee
    can be congratulated for the work they have done over the past decades. We look forward to continuing to
    work with all the members of the GHTF towards harmonised regulations which will enhance public health.
    Both EDMA and Eucomed fully support the work done by the GHTF and will remain active partners in the work
    of the future GHTF.
    The transition planning by regulators and industry is underway.

    About Eucomed
    Eucomed is the European medical technology industry association. Its mission is to improve patient and
    clinician access to modern, innovative and reliable medical technology. Eucomed represents directly and
    indirectly 22,500 designers, manufacturers and suppliers of medical technology used in the diagnosis,
    prevention, treatment and amelioration of disease and disability. Small and medium sized companies
    make up more than 80% of this sector. The European medical technology industry generates annual
    sales of 95 billion, invests some 7.5 billion in R&D and employs around 500,000 highly skilled workers.
    For more information visit www.eucomed.org

    About EDMA
    EDMA, the European Diagnostic Manufacturers Association, represents national trade associations and
    major companies engaged in the research, development, manufacture or distribution of In Vitro
    Diagnostic (IVD) medical devices in Europe. Through its affiliated associations, EDMA represents more

    PRESS RELEASE

    than 500 companies across Europe. The mission of EDMA is to raise awareness of the importance and
    added value diagnostic information provides to healthcare. EDMA cooperates with European institutions,
    patients groups, trade associations, health professionals and academia to support an appropriate
    regulatory system, to work towards a realistic economic environment for healthcare and to be an effective
    voice in globalisation.

    More information
    Ingmar de Gooijer
    Eucomed
    Director Communications
    E: ingmar.degooijer@eucomed.org
    T: +32 (0)2 775 92 24
    M: +32 (0)492 97 14 70
    Daniele Dosi
    EDMA
    Communications Officer
    d.dosi@edma-ivd.be
    Tel. +32 (0)2 777 02 78

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