AMTAC to pursue notified body status for IVDs (in vitro diagnostics):
This article was originally published in Clinica
AMTAC, a UK notified body for medical devices, is seeking to become notified for in vitro diagnostics under the new European Union IVD Directive. However, it sees this as a "very limited market compared to medical devices", David Gale, director at AMTAC, said. The testing and certification organisation is discussing links with a private testing laboratory, but has not yet reached an agreement. "We have every intention of pursuing this market opportunity, but do not see it as a major market for the future, rather as an added weapon in our armoury," Mr Gale said.
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