Legislation - EU directives

The EU Tissue and Cell Directives

The use of tissue and cell-based medical treatments is rising in both number and frequency thanks to significant advances in biotechnology.
Blood-forming stem cells are transplanted from bone marrow donors (or cord blood) to patients with blood cancer, and/whereas gametes are used for in-vitro fertilisation (IVF). Both are well known medical therapies that use human cells. Other invaluable uses of human tissues include skin grafting for burn victims, or corneal grafting to restore sight.
Bone marrow (haematopoietic stem cells) and gametes (sperm, egg cells) for IVF can be donated by living donors, while replacement tissues (like skin, bone, cornea or heart valves) can be donated after death.

The legal framework defining the safety and quality standards for tissues and cells is set out in Directive 2004/23/EC, also referred to as the European Tissues and Cells Directive, adopted in 2004 by the European Parliament and Council. It covers all steps in the transplant process from donation to distribution, including procurement, testing, processing, preservation and storage.

To help implement this basic act, the Commission proposed and adopted, in close collaboration with EU countries, the following implementing Directives:

  • Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004
    applies to the donation, procurement, testing, preservation, storage and distribution of human tissues and cells intended for human use (including reproductive cells used in ART procedures).

  • Commission Directive 2006/17/EC 
    established specific technical requirements for the human tissue and cell procurement and preparation processes. It was amended in 2012 by Commission Directive 2012/39/EU with regard to certain technical requirements for the testing of human tissues and cells.

  • Commission Directive 2006/86/EC
    Includes traceability requirements, notification of serious adverse reactions and events, and technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. It was amended in 2015 by the Directive 2015/565 that provides requirements on the coding of human tissues and cells.

  • Directive 2015/566 implementing directive on the procedures for verifying equivalent standards of quality and safety of imported tissues and cells.


Read more on: https://ec.europa.eu/health/blood_tissues_organs/tissues_en