Medical technology industry calls for regulatory convergence in U.S.-E.U. trade deal

Press release

Washington, D.C., 12 April 2013 – The medical technology industry represented by AdvaMed, COCIR, Eucomed, EDMA and MITA met yesterday with senior U.S. and E.U. government officials as part of the U.S.-E.U. High Level Regulatory Cooperation Forum urging them to consider regulatory convergence for medical technology in upcoming negotiations on the Transatlantic Trade and Investment Partnership (TTIP).

At the meeting, our joint delegation outlined the importance of our technologies and the opportunities they bring to advance a sustainable healthcare system in the U.S. and E.U. Our industry is focused on making TTIP a matter of high importance that will bring measureable results in the short and mid-term such as 1) mutual recognition of ISO 13485, 2) a single audit process, 3) harmonized format for product registration submission and 4) a common way to trace products through a single unique device identification (UDI) process with interoperable databases.

As the single largest free trade agreement in history, TTIP will promote E.U. and U.S. international competitiveness, create jobs and grow our respective economies,” said Stephen Ubl, President of AdvaMed. “Trade in goods and services between the E.U. and U.S. accounts for nearly one trillion U.S. dollars and supports millions of jobs. This agreement could create new jobs that will improve access to the life-saving medical technologies that E.U. and U.S. companies manufacture,” noted Serge Bernasconi, Chief Executive Officer of Eucomed and EDMA. The economic relationship between the U.S.-E.U. is the largest in the world, accounting for half of all global economic output, and the medical technology industry looks forward to continued engagement as negotiations move forward.

Success here will set the scene and encourage other economies to join in the effort to increase patient access to high-quality healthcare to billions of citizens that many Americans and Europeans enjoy,” said Gail Rodriguez, Executive Director of MITA. “With our industry working on a global scale, we clearly see the benefits of greater regulatory harmonization: life-saving medical technologies reach patients that need them most more efficiently by reduced time and cost for these products to be approved,” added Nicole Denjoy, Secretary General of COCIR.

The medical technology industry enthusiastically supports this opportunity, and looks forward to concrete developments of this highly regarded initiative.

The full joint EU-US medical technology industry contribution to the EU and US call for input on opportunities to promote greater regulatory compatibility in the medical technology sector is available for download here.

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About EDMA

EDMA, the European Diagnostic Manufacturers Association, advocates for the interests of the in vitro diagnostic industry and its enormous contribution to transforming healthcare systems by improving healthcare efficiency and reducing costs. EDMA’s strength lies in its close co-operation with European institutions, patients groups, trade associations, health professionals, and academia, working together to shape the EU policy that will have the most impact on the lives of Europeans and reinforce the European IVD industry’s voice globally. From small businesses to major corporations, the European in vitro diagnostic industry is a market worth around 11 billion euro. Driven by research and development, 95% of the industry is comprised of small and medium size enterprises and approximately 1 billion euros per year is reinvested in R&D. EDMA is a member of MedTech Europe, an alliance of European medical technology industry associations. For more information, visit

About Eucomed

Eucomed is the European medical technology industry association. Its mission is to make modern, innovative and reliable medical technology available to more people. 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. Eucomed is a member of MedTech Europe, an alliance of European medical technology industry associations. For more information visit

About AdvaMed

AdvaMed is the Advanced Medical Technology Association that represents medical device and diagnostics manufacturers in the United States.


COCIR is the voice of the European Radiological, Electromedical and Healthcare IT Industry.

About MITA

MITA is the collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers in the United States.


More information

Ingmar de Gooijer
Director Communications MedTech Europe, Eucomed, EDMA
T: +32 (0)2 775 92 24
M: +32 (0)492 97 14 70