Module 18 2021

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

9

TOPRA MSc Module 18: Drug Device Combinations and other Technology