Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Non-viable cells

● Non-viable tissues and cells themselves are not covered (unless part of a device where they have an ancillary action) (Article 1.10) ● So these products are human tissue products (2004/23/EC) if they are not medicinal products

Decellularised human dermis

Demineralised bone

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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Regulation of Human Cells and Tissues in the EU

Combined ATMPs

ATMPs

Medical Devices

Human Tissue Products

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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