Module 18 2021

Quality and safety regulations for human tissues

All clinical use of human tissues subject to EU directive 2004/23/EC, except for: ● tissues and cells used for autologous use within the same surgical procedure ● blood and blood components (Directive 2002/98/EC) ● organs or parts of organs if they are to be used for the same purpose as the entire organ in the human body (Directive 2010/45/EU) • Includes transplants such as bone marrow, cornea, heart valves for homologous use

• Similar to HCT/Ps regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 in US

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TOPRA MSc Module 18: Drug Device Combinations and other Technology