Medical industry leaders push for U.S.-EU rules convergence

Medical technology industry leaders on both sides of the Atlantic have come together in a push for regulatory convergence as part of the U.S.-EU High Level Regulatory Cooperation Forum.

AdvaMed; the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR); the European Confederation of Medical Devices Associations (EUCOMED); the European Diagnostic Manufacturers Association (EDMA); and the Medical Imaging and Technology Alliance (MITA) met with senior U.S. and European Union (EU) government officials at the forum to promote the adoption of regulatory convergence for medical technology in upcoming negotiations on the Transatlantic Trade and Investment Partnership (TTIP).

A joint delegation of the healthcare technology organizations outlined the importance of their technologies and their promise in advancing sustainable healthcare in the U.S. and Europe, according to the groups.

The group hopes to make TTIP a matter of high importance at the cooperation forum, one that will bring measurable results to the healthcare industry, said the organizations, whose goals include the following:

  • Mutual recognition of the International Organization for Standardization (ISO) standard 13485, the 2003 ISO standard that defines the requirements for comprehensive quality management in the design and manufacture of medical devices
  • A single audit process
  • Harmonized format for product registration submission
  • A common method of tracing products via a single unique device identification process with interoperable databases

TTIP will be the largest free trade agreement in history, promoting international competitiveness between the U.S. and the EU, which together account for about $1 trillion in goods and services, AdvaMed said. A technology agreement could create new jobs that will improve access to lifesaving medical technologies that firms manufacture and patients benefit from on both continents, the organizations said.

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