EU Tissue and Cells Directive

EU Tissue and Cells Directive via the Human Tissue (Quality and Safety for Human Application) Regulations 2007.

The European Union Tissue and Cells Directives (EUTCD) set out to establish a harmonised approach to the regulation of tissues and cells across Europe. The Directives set a benchmark for the standards that must be met when carrying out any activity involving tissues and cells for patient treatment. The Directives also require that systems are put in place to ensure that all tissues and cells used in patient treatment are traceable from donor to recipient. The Directives were fully implemented into UK law on 5 July 2007, via the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). The Human Tissue Authority's (HTA) remit was extended by the Q&S Regulations to include the regulation of:

  • procurement,
  • testing,
  • processing,
  • storage,
  • distribution and
  • import / export

of tissues and cells for human application. Organisation where these activities are carried out will normally need a license.

The organisations carrying out the above activities are required to meet the standards which are detailed in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA Directions 003/2010.

Further information about EU tissue and cells directives can be found on the HTA website.