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U.S./EU MRA

This article was originally published in The Gray Sheet

Executive Summary

FDA expects to complete dossier review of TUV Product Services and SGS Yarsley - two EU Conformity Assessment Bodies - by February, which would clear the way for independent premarket reviews and quality systems inspections by the organizations. The agency estimates 55 premarket reports and 165 quality systems reports will be generated and required to be maintained by EU CABs annually, once the Mutual Recognition Agreement medical device annex is fully underway, according to a Jan. 14 Federal Register notice. A decision on how much longer the confidence-building phase of the MRA should be extended is still under consideration by EU and U.S. reps, but the decision could be made in the next month, according to FDA staffers. The confidence building phase was to end Dec. 7, 2001, however, it likely will be extended by at least one year...
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