Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

CLP – 1272/2008 Classification, labelling and packaging of hazardous substances regulation

The Organisation for Professionals in Regulatory Affairs

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BPR – 528/2012 Biocidal Products Regulation

 Regulation – Published 22 May 2012 (last amendment made via 2021/407 March 2021 • Managed by ECHA • ECHA BPR Guidance • A biocide is a substance or mixture that will render a harmful organism harmless by means other than physical or mechanical action. • Finished IVDs are exempt, no reference made in IVDR • Manufacturers may be impacted if RUO product or products other than finished IVDs are sold by them and they contain BPs • May only use substance approved under Article 95 and it must be sourced from an approved supplier

The Organisation for Professionals in Regulatory Affairs

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