Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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

• Product must be correctly labelled with the WEEE symbol

• Products must be registered on the national registry of products, input is quantity of product, by weight, placed on the market

• Easier to join a compliance scheme, they will manage lifecycle and ensure products are dealt with appropriately

• Must report, by weight, EEE or WEEE separately collected, recycled, recovered, and disposed of and or shipped within or outside EU

The Organisation for Professionals in Regulatory Affairs

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EMC – 2014/30/EU Electromagnetic Compatibility Directive

 Directive – Published 26 February 2014 • Referenced in IVD Regulation preamble paragraph 14 and chapter I section 1 Article 1 • IVDR takes precedent as GSPR requires electromagnetic compatibility Annex I chapter II 13.2(b) • Annex I Chapter II 17.3 reference need to design to prevent creation of Electromagnetic interference • 17.4 references need for devices to be designed to provide immunity to electromagnetic interference • If required must mention in IFU

The Organisation for Professionals in Regulatory Affairs

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