Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

ABP – 1069/2009 Animal by-products Regulation

• Finished IVDs are exempt

• Intermediate products – products which have been processed and are for IVD use e.g. purified sheep antibodies then Model chapter 20 declaration may be used • Manufacturers exporting and or receiving ABP must be registered for UK this is with Animal and Plant Health Agency • Each EU member state has different requirements so confirm with

local Competent Authority e.g. UK = DEFRA • TRACES (Trade Control and Expert System

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94/62/EC Packaging and Packaging Waste Directive

 Directive – Published 20 December 1994 • Covers all packaging placed on market and all packaging waste • Primary packaging e.g. individually packaged pregnancy test • Secondary packaging e.g. multiple sales units, box of 10 pregnancy tests • Shipping and transport packaging • Important to consider if manufacturer is looking for certification ISO 14001 Environmental Management Systems • Reporting requirements • Green Dot symbol - Users obtain a license to use, voluntary in most of EU member states Not recognised in UK

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