Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

94/62/EC Packaging and Packaging Waste Directive

• UK has Packaging Regulation : SI 2015 1640 • Requirement for a Responsible Person • Uses Schedule 1 Essential requirements (Annex II of directive • Must minimise packaging • Must be recyclable where possible • IVDD/IVDR Essential Requirements for appropriate packaging to ensure essential performance applies.

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

 The RoHS directive (RoHS2 and RoHS3 ) applies to electrical and electronic equipment • RoHS2 took effect 21 July 2011 • This formally identified Lead, Mercury and Cadmium plus 3 others • Became a CE marking directive, Technical File and DoC required (Article 13 for Model DoC) • Became effective for IVDs 22 July 2016 • Items non-compliant placed on market before effective date can continue to be put into service • Non-compliant spare parts recovered from items placed on market before effective date can still be used for other instruments already placed on market until 22 July 2023

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