Module 18 2021

Medical Devices and Human Tissues

● Current Directive 93/42/EEC – Article 1.5(f)

– “this directive does not apply to transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin” – But ATMP Regulation 1394/2007/EC (Article 2.1(b)) excludes tissue engineering products made of non-viable cells and not acting primarily by pharmacological, immunological or metabolic means

Example – collagen fillers

– so these products are not medicines or devices.

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TOPRA MSc Module 18: Drug Device Combinations and other Technology