Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

● Directive addresses: – Donation, Procurement, Donor Testing* – Processing, Preservation, Storage, Distribution – Sets the requirement for these activities to be performed by an accredited Tissue Establishment (TE) ● Directive sets out minimum requirements – Inspections – Traceability – Import/export – Donor selection, consent and data protection – Responsible person at TE ● Similar requirements laid out in section 361 of the PHS Act and 21 CFR Part 1271 in US Council Directive 2004/23/EC (as amended)

*Only these requirements apply if manufactured products are covered by another directive e.g. medicinal products, devices 5 TOPRA MSc Module 18: Drug Device Combinations and other Technology

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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

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