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New list of harmonised devices:

This article was originally published in Clinica

Executive Summary

The European Commission has published in the Official Journal of the European Communities a series of standards that it accepts as giving presumption of conformity with the essential requirements of the Medical Devices Directive and the In Vitro Diagnostics Medical Devices Directive. This means that products that comply with these standards are accepted as meeting the relevant requirements listed in the directives. These range from standards for medical gloves to medical equipment standards. For a full listing, see the Official Journal of November 14, 2001, section C.

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