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UL International scores IVDD (In Vitro Diagnostics Directive) first in UK

This article was originally published in Clinica

Executive Summary

UL International (UK) has become the first and so far "only notified body in the UK" designated to test all products covered by the In Vitro Diagnostics Directive (IVDD) against all annexes. Following its initial designation in September 2000, the Guildford, Surrey-based company has just received authorisation from the UK's regulatory authority, the Medical Devices Agency, to audit all high-risk products in annex II of the directives, as well as self-test IVDs.

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