US-EU Regulatory Convergence: US and EU Trade Agreement Brings Industries Together

Preparing for negotiations related to the Transatlantic Trade and Investment Partnership (TITP), a new international trade agreement between the US and the EU, five medical technology industry associations representing US and EU manufacturers met yesterday to campaign for a convergence in regulation between the two markets. The five bodies are medical device manufacturing associations AdvaMed of the USA and Eucomed of Europe, the European Diagnostics Manufacturers Association (EDMA), the Association of Electrical Equipment and Medical Imaging Manufacturers of the USA (MITA) and COCIR—the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry.

The TITP is described as an ambitious, high standard trade and investment agreement. It is hoped to provide significant benefit in terms of promoting US international competitiveness, jobs, and growth.

The following press release was published by Eucomed.

MITA met yesterday with senior US and EU 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 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 US and EU 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 EU and US international competitiveness, create jobs and grow our respective economies,” said Stephen Ubl, President of AdvaMed. “Trade in goods and services between the EU and US 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,” noted Serge Bernasconi, Chief Executive Officer of Eucomed and EDMA. The economic relationship between the US-EU 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.

Image source: euintheus.org.