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EU notified body extends IVD (In Vitro Diagnostics) testing scope:

This article was originally published in Clinica

Executive Summary

The EU notified body, UL International, has been authorised by the UK Medical Devices Agency to extend its testing scope under the EU In Vitro Diagnostics Directive. Now, in addition to full quality assurance testing (Annex IV) of toxoplasma, rubella, cytomegalovirus and chlamydia, the organisation may audit prostate specific antigen tests. In addition, it now offers Annex III testing, EC declaration of conformity - design examination, of self-tests for determining pregnancy and ovulation; and self-tests for determining cholesterol levels.

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