Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

RoHS – 2011/65/EU Restriction of Hazardous Substances Directive

• RoHS3 took effect 31 March 2015 • Recast of RoHS2 to RoHS3 • 4 more substances added to Annex II identified endocrine disrupters • Mainly related to plasticisers in PVC • Impact to IVD is mainly cabling and micro processors • Compliance for IVDs required by 22 July 2021

The Organisation for Professionals in Regulatory Affairs

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WEEE – 2012/19/EU Waste Electronic and Electrical Equipment Directive

 Directive – Published 04 July 2012 • Annex I includes Medical Devices and IVDs but excludes infected and implantable devices • From 15 August 2018 directive has not applied to devices where they are expected to be infective prior to end of life e.g. considerable contamination not cleanable • Directive is to ensure recycling and correct disposal of waste EEE to reduce amount of EEE in landfill

The Organisation for Professionals in Regulatory Affairs

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