Module 18 2021

Council Directive 2004/23/EC

● 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

*Only these requirements apply if manufactured products are covered by another directive e.g. medicinal products

5

TOPRA MSc Module 18: Drug Device Combinations and other Technology