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EU recognises pivotal device standards:

This article was originally published in Clinica

Executive Summary

The titles of three key quality system standards for the medical device industry were published in the Official Journal of the European Communities on July 31. EN ISO 13485 and EN IS0 13488 are both internationally accepted medical device quality system standards that are intended to replace EN 46001 and EN 46002 in Europe. Their publication indicates that once manufacturers meet these requirements, they are presumed to be in conformity with the relevant requirements of the medical device directives. These earlier medical device quality system standards needed updating in the light of the publication in 2000 of the generic quality system standard, ISO 9001:2000, and become redundant on March 1 2004. Also published on July 31 is EN ISO 14971, a horizontal standard on the application of risk management to medical devices. This will supersede the European risk standard was EN 1441, which becomes redundant on April 1 2004.

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