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EU Tissues and Cells Directive

  • Last modified date:
    26 April 2007

Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.

The EU Tissues and Cells Directive sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells intended for human application. It was adopted by the European Parliament on 7th April 2004.

The Directive covers all human tissue except for:

  • tissues and cells used as an autologous graft within the same surgical procedure,
  • blood and blood components as defined by Directive 2002/98/EC and
  • organs and parts of organs if the parts are to be used for the same purpose as an entire organ.

The Directive does cover gametes (sperm and eggs) and embryos.

Public consultation on new Regulations

More information on this Directive is available on the page below

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