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France to have second notified body from January: d

This article was originally published in Clinica

Executive Summary

France is to have a second notified body (NB) for medical devices diagnostics. The health ministry has accredited the National Testing Laboratory, the Laboratoire Nationale d'Essais, to begin work as from January 1 2005, according to a Decision that appeared in the Journal officiel of November 14. The LNE has been accredited to test: active implantables against annexes II to V of the Active Implantable Medical Device Directive; all medical devices, including class I sterile and with a measuring function, against annexes II to VI of the Medical Devices Directive; and self-testing and Annex II diagnostic products (lists A and B) against annexes III to VII of the IVD Directive. G-Med is the other French NB.

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