The number of withdrawals of medical device certificates by notified bodies has increased nearly 400%, from approximately 230 in 2010 to 915 in 2012, according to a survey by the European association of medical device notified bodies, or TEAM-NB. Association President Gert Bos attributes the increase in withdrawals to stricter requirements for clinical evidence, increased certification reporting and closer scrutiny by authorities.
Survey shows big jump in medtech denials by EU notified bodies
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