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L'industrie médicale de technologie réclame les États-Unis - E.U. convergence de normalisation

par Nancy Ryerson, Staff Writer | April 16, 2013
Nicole Denjoy,
the COCIR Secretary General
MITA and other members of the medical technology industry met with senior U.S. and E.U. officials to urge them to bring regulatory convergence to the industry, a step they said will help the industry create jobs and encourage innovation.

Representatives from AdvaMed, COCIR, Eucomed, EDMA and MITA met on April 10 to urge the officials to consider regulatory convergence for medical technology in upcoming negotiations on the Transatlantic Trade and Investment Partnership (TTIP).

As the economic relationship between the U.S. and the E.U. is the largest in the world, Denjoy and the medical technology industry feel that easier regulations will lead to expansions and even more job opportunities.

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"If the systems are efficient, that means enterprises can expand innovations," said Nicole Denjoy, Secretary General of COCIR, to DOTmed News. "I'm sure there are a lot in the U.S. that have not been approaching the other constituents, so if we have less of a regulatory burden, that means it will be easier for those companies to bring those important technologies abroad."

As it stands now, there are several regulatory inconsistencies between the U.S. and the E.U. For example, the two do not accept reports of each other's audits, and Unique Device Identification labeling differs between the U.S. and E.U.

The industry hopes to smooth the regulatory process with a single audit process, a harmonized format for product registration submission and an interoperable UDI database.

In terms of a timeline, the industry believes an audit program that works for both the E.U. and the U.S. could be in place within two years of a TTIP. Industry presenters said they hoped a UDI database for both regions could be put into place in the short-term, as the U.S. Food and Drug Administration already has a UDI database that has been tested.

Denjoy and the other industry representatives hope to eventually expand regulatory convergence to other parts of the world.

"If we can make one step concrete to show how can it be possible between E.U. and U.S., then we believe that it will be easier to create some archetype with the other world economies," said Denjoy.

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