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Austrian notified body for IVDs (in vitro diagnostic's) on the horizon:

This article was originally published in Clinica

Executive Summary

TUV Austria has applied to its national authority for designation as a notified body under the European Union's In Vitro Diagnostics Directive. It expects notification for the following products in annex II, list A (high-risk) as a first step: HIV, blood typing products and self-tests. It then plans to extend its scope to all list A products and high-volume tests from list B. It will subcontract some work to the Austrian federal Institute of Medicines and is considering using other subcontractors. For more details, contact Robert Messner. Fax: +43 1 61091 89 (e-mail: me@tuev.or.at).

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