European Industry Decries Broad MDD Regrouping Sought By UK, France
This article was originally published in The Gray Sheet
Executive Summary
Upclassification of artificial joint products under the Medical Devices Directive (MDD) could result in an EU market shortage of devices used in hip replacement surgery, according to European manufacturers
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Quality systems technical report: Final version of Technical Report 14969, which provides guidance on device use quality systems standard ISO 13485:2003, is expected by late spring or early summer, BSI Assistant VP-Product Services Paul Brooks tells participants at Regulatory Affairs Professionals Society Principles & Practices of EU Regulatory Affairs meeting Feb. 23-24 in Arlington,Va. TR 14969 previously was a guidance standard, but was changed to a technical report with the update of ISO 13485 (1"The Gray Sheet" July 2, 2001, p. 14). The ISO quality standard will replace its 1996 predecessor in July 2006...
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