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International Medical Device Regulatory Monitor
November 2012 | Vol. 20 No. 11
Revised Conduct Code for Notified Bodies Details Unannounced Audits
European notified bodies (NB) must conduct unannounced inspections of medical devicemakers at least once every three years for Class I, IIa and IIb devices and once every two years for Class III and active implantable medical devices (AIMD), according to the new code of conduct released by the European Association of Notified Bodies Oct. 10.
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