Medical Technology Industry Calls for Regulatory Convergence in US-EU Trade Deal

April 11, 2013—The medical technology industry in the United States and Europe is calling for regulatory convergence between the two markets.

The joint announcement was made by AdvaMed (the Advanced Medical Technology Association, representing medical device and diagnostics manufacturers in the United States), Eucomed (the European medical technology industry association), COCIR (the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry), and EDMA (European Diagnostic Manufacturers Association; representing the in vitro diagnostic industry), and MITA (Medical Imaging & Technology Alliance; representing medical imaging equipment, radiation therapy, and radiopharmaceutical manufacturers in the United States).

According to the industry groups' joint press release, representatives from AdvaMed, Eucomed, COCIR, EDMA, and MITA met with senior United States and European Union government officials as part of the US-EU 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, the industry delegation outlined the importance of medical technologies and the opportunities they bring to advance a sustainable health care system in the United States and European Union.

The industry groups stated that they are focused on making TTIP a matter of high importance that will bring measureable results in the short and midterm, which include mutual recognition of ISO 13485; a single audit process; harmonized format for product registration submission; and a common way to trace products through a single unique device identification (UDI) process with interoperable databases. ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Nicole Denjoy, Secretary General of COCIR, said, “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.”

The groups noted that the economic relationship between the United States and European Union 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.

In the press release, AdvaMed President and Chief Executive Officer Stephen J. Ubl commented, “As the single largest free trade agreement in history, TTIP will promote EU and US international competitiveness, create jobs, and grow our respective economies.”

Serge Bernasconi, Chief Executive Officer of Eucomed and EDMA, stated, “Trade in goods and services between the European Union and United States accounts for nearly one trillion US dollars and supports millions of jobs. This agreement could create new jobs that will improve access to the life-saving medical technologies that EU and US companies manufacture.”

Gail Rodriguez, Executive Director of MITA, stated, “Success here will set the scene and encourage other economies to join in the effort to increase patient access to high-quality health care to billions of citizens that many Americans and Europeans enjoy.”