European Regulations for Reproductive Tissue Banks

The EU Tissues and Cells Directive (EUTCD; Directive 2004/23/EC) with all its directives and amendments regulates procurement, processing, distribution and storage of cells (sperm, oocytes, and zygotes), and tissues (embryos, testicular, and ovarian tissue) without intervening with national legislation. EU tissue establishments need authorization and licensing by the national competent authorities, and they have to designate a “responsible person” who is legally liable. All aspects, such as risk management, donor recruitment and particularly testing, traceability and coding, as well as the reporting of serious adverse reactions and events are strictly regulated. Less regulation is noticeable concerning all processes in the lab as long as it is guaranteed that these are performed according to standard operation procedures within a functioning quality management system. Currently, the EUTCD is in revision.