Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Medical Devices and Human Tissues

● Previous 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 were not medicines or devices.

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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Devices Regulation (EU) 2017/745 (Medical Device Regulation (MDR))

Article 1 - Scope ● 6. This Regulation shall not apply to – g. transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable

● So this type of product now brought under regulatory control as medical devices

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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