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In Brief: U.S./EU device MRA

This article was originally published in The Gray Sheet

Executive Summary

U.S./EU device MRA: April 25 teleconference between U.S. and European Union negotiators on a medical device mutual recognition agreement outlines remaining work to be done but produces no substantial headway on key issues of product coverage and identification of notified bodies, FDA staffers say. The next teleconference is set for May 5, with agency seeking possible face-to-face meetings in Washington or Brussels during the weeks of May 12 or May 19. An April 19 letter from EU President Jaques Santer to President Clinton places additional pressure to complete negotiations before a May 28 Summit meeting in The Hague, The Netherlands. That correspondence urges Clinton to take "personal intervention" in the MRA negotiations and notes that in medical devices and drugs, "the product coverage proposed by the U.S. side is far too limited and the commitment to recognize the results of our assessments too lose"...

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