Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

BPR – 528/2012 Biocidal Products Regulation

 Sodium Azide is under review for inclusion on list • Widely used in IVD industry as preservative • MedTech Europe are lobbying EU Commission to exempt R&D use

As with REACH products are regularly added for review

The Organisation for Professionals in Regulatory Affairs

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ABP – 1069/2009 Animal by-products Regulation

Regulation – Published 21 October 2009 • Not managed by ECHA • Publish health and animal health rules for handling and use of ABP and derived products • Aims to prevent or minimise risks in particular protect safety of food and feed chains • Implementing Regulation 142/2011 has detail and model declarations for use for import/export

The Organisation for Professionals in Regulatory Affairs

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