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U.S./EU mutual recognition agreement

This article was originally published in The Gray Sheet

Executive Summary

Changes to the list of devices covered under the MRA should be approved by the European Commission rather than by each European member state, the Health Industry Manufacturers Association says in a Sept. 30 letter to U.S. State Department Ambassador Stuart Eizenstat. HIMA expresses concern that allowing each member to consider the issue "could create problems and result in significant delays in implementation of the MRA." Both FDA and the EU have expressed a willingness to expand the current MRA device list to match the products covered under the agency's domestic third party "Accredited Persons" program
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