Human Tissue (Quality and Safety for Human application) Regulations 2007

The Human Tissue (Quality and Safety for Human application) Regulations 2007 transposed the European Union Tissues and Cells Directives (EUTCD) into UK law. The purpose of the EUTCD was to set minimum standards for protecting the quality and safety of tissues and cells to be used for patient treatment ("human application"), harmonising the European approach.  

The regulations require any UK organisation carrying out the:

  • procurement
  • testing
  • processing
  • storage
  • distribution
  • import or export

of tissues and cells for patient treatment to be licensed by the Human Tissue Authority and inspected every two years.

Royal Brompton & Harefield NHS Foundation Trust's heart valve bank is licensed under the regulations for all of the above activities in relation to heart valves for transplantation. View more information about the heart valve bank's Human Tissue Authority licences.

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