Medtech Industry Bids To Get Rid Of Transatlantic Regulatory Anachronism

In short

That the Western world’s medical devices are regulated so differently can make no sense. The two systems have evolved along paths so separate that Darwin could have concluded that, like regulatory Galapagos finches, we never crossed paths. Now it seems industry is behind moves to integrate our regulatory rules into one uniform system under a new Transatlantic trade partnership. Either that or just a bit more convergence.


The medical technology industry represented by AdvaMed, COCIR, Eucomed, EDMA and MITA met yesterday (April 10th) 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, the joint delegation outlined the importance of the medical technologies it represents, and the opportunities they bring to advance a sustainable healthcare system in the U.S. and E.U.

Eucomed, in a press release issued today, says the medtech industry is focused on making TTIP a matter of high importance that will bring measurable results in the short and mid-term. TTIP is indeed a good lever with which to beat the regulators either side of the pond. And it’s not as though the various bodies are calling for complete harmonisation (yet), although just imagine a world in which you only had to chase one big regulatory approval to have the entire western world markets open up.

For now, what is being called for is a mutual recognition of ISO 13485, a single audit process, a harmonised format for product registration submission and a common single unique device identification (UDI) process with interoperable databases.

Industry body comments

“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. “Greater regulatory harmonization will bring life-saving medical technologies to the world market more efficiently by reducing the time and cost it takes products to reach patients that need them most, especially as our industry is already working on a global scale,” added Nicole Denjoy, Secretary General of COCIR.

Source: Eucomed