Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

Risk Classification

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When is Rule 21 not applicable

• Non-invasive conductive gels such as ultrasound gels • Medical devices used in vitro • Rule 3 devices for extracorporeal treatment of body fluids / tissues / embryos for reintroduction into the body • Solution of organ preservation and transportation • IVF Media • Surgically Invasive devices • Drug Eluting Stents • Bone Cements

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