11% of employees are dedicated to R&D. 11 billions IVD market size 3,000 companies 75,000 people employed. 40,000 IVD products
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1 About edma
2 EDMA The European Diagnostic Manufacturers Association is an international, non-profit organisation representing the interests of the European in vitro diagnostics industry at the European and international levels. About In Vitro Diagnostics In vitro diagnostics (IVDs) are non-invasive tests used on biological samples (for example blood, urine or tissues) to determine the status of one s health. IVDs provide valuable information on how the body is functioning. They are used for diagnosis, screening, assessing predispositions and therapeutic monitoring of diseases. Innovations in IVDs contribute to cutting costs in healthcare systems by making treatment more precise and efficient. IVDs have a broad scope ranging from sophisticated technologies performed in clinical laboratories to simple self-tests, such as those for pregnancy and glucose monitoring. Facts about IVDs IVDs are tests used on samples taken from human body to determine status of one s health. IVDs never come in contact with the person or patient. IVDs do not treat patients. European In Vitro Diagnostics industry in numbers 11 billions IVD market size 3,000 companies 75,000 people employed 40,000 IVD products 11% of employees are dedicated to R&D 95% of the industry is SME based
3 Our Mission EDMA is continuously engaged with policymakers and stakeholders in the European and international arenas. Our mission is four-fold: Promote the value of in vitro testing in healthcare decision-making and in sustainability of European healthcare systems; Contribute to the development of legislative and regulatory framework that will shape the industry s future; Provide technical, regulatory, and market research information to our members; Represent the European IVD industry at global platforms and organisations such as the WHO. Our Members National associations representing more than 500 small and medium size enterprises in Europe; Corporations engaged in the research, development, manufacturing or distribution of in vitro diagnostics; Organisations contributing to the overall development or advocacy of in vitro diagnostics.
4 Our Work Expertise Develop industry positions on topics such as changes in legislation and Health Technology Assessment (HTA) and more; Act as the knowledge centre on how to interpret and comply with EU and international regulatory requirements as well as European market access policies; Provide guidance on how to conduct business ethically and responsibly at all times. Advocacy & Communications Promote the value of the IVD industry and engage in relevant EU policies and initiatives; Collaborate with policy and decision makers, as well as those responsible for market access; Act as reputation stewards for the IVD industry and explain the value of IVDs through targeted campaigns and events such as the MedTech Forum. Membership services Support members in developing and conducting policy analysis and advocacy plans; Provide members with a comprehensive overview of the latest market trends; Publish the Global Diagnostics Market Statistics (GDMS), issued every quarter and the Management Information System (MIS), issued once every month; Offer comprehensive data, detailed on the European market that can also be refined for sectors and specific markets of interest. Our Staff By engaging with European and international stakeholders and monitoring global initiatives, EDMA analyses key developments and provides summaries of complex legislation for its members, including national associations, small and medium enterprises and large corporations. The secretariat, based in Brussels, runs the day-to-day operations of the association, encompassing everything from logistics to stakeholder outreach. Founding member of MedTech Europe alliance EDMA, representing the in vitro diagnostic industry and Eucomed, representing the medical technology industry in Europe are the founding members of MedTech Europe. MedTech Europe is an alliance of European medical technology industries, and was established to represent these industries more effectively and provide stakeholders with one unified discussion platform when needed. Visit for more information.
5 Become a member Operating in the heart of the European Union, EDMA offers its members the unique opportunity to be involved in European policy-making, without having to be in Brussels. Shape EU policy to define the IVD industry; Receive timely guidance and technical assistance reflecting legislative and regulatory developments; Gain market intelligence to understand IVD market tools; Save time and money by gaining access to exclusive expert opinion on and offline; Strengthen the European IVD industry s voice in the global arena. Value of In Vitro Diagnostics Prediction Currently, genetic testing is estimated to be available for some 2,000 clinical conditions, with the number of available diagnostic tests increasing exponentially. Preparing for Precision Medicine Report by World Economic Forum 2012 Screening Implementation of universal diagnostic testing in the public and private sectors would substantially reduce the global requirements for antimalarial treatment. World Malaria Report, WHO 2012 Diagnosis In resource-limited settings, the impact of diagnostic tests that can be provided at the immediate point-ofcare (a point-of-care test, or POCT) is potentially even greater, because the alternative to a POCT may be no diagnostic support at all. American Academy of Microbiology 2012 Monitoring Current evidence suggests that using self-monitoring of blood glucose in this population has the potential to improve glycaemic control, especially when incorporated into a comprehensive and ongoing education programme that promotes management adjustments according to the ensuing blood glucose values. Self-monitoring of blood glucose in Non-Insulin Treated Type 2 Diabetes Guideline, International Diabetes Federation
6 member of European Diagnostic Manufacturers Association Tel Fax edma@edma-ivd.eu
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