The new European medical device directives are expected to be adopted this fall, implemented by the end of 2008 and enforced by 2010, Cristiana Spontoni, European partner with Squire, Sanders & Dempsey, said at the recent FDAnews Medical Device Quality Congress.
The European Parliament recently approved the amendments to the directives. The amendments narrow the definition of a single-use device and obligate the European Commission to further study the practice of reprocessing single-use devices, according to Spontoni.
http://www.fdanews.com/newsletter/article?issueId=10357&articleId=95035
e hënë, 25 qershor 2007
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