Survey shows big jump in medtech denials by EU notified bodies

06/16/2013 | Clinica

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.

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