Tissues and Cells Legislation

Below is a list of the national and European legislation for the regulation of tissues and cells.

European Legislation

  • Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
  • Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells.
  • Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.
  • Commission Directive 2012/39/EU of 26 November 2012 amending Directive 2006/17/EC as regards certain technical requirements for the testing of human tissues and cells.
  • Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.
  • Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells. 
  • Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC

National Legislation

  • S.I. No. 158/2006 - European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006.
  • S.I. No. 598/2007 - European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007.
  • S.I. No. 209 of 2014- European Communities (Quality and Safety of Human Tissues and Cells) (Amendment) Regulations 2014.
  • S.I. No. 32 of 2019 - European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) (Amendment) Regulations 2019.