Blood, tissues and organs


The availability of donor organs is often a question of life and death for patients requiring a transplant. With transplantation now a commonplace technique, one of the main factors limiting the number of transplants is the shortage of organs.

The Communication on organ donation and transplantation adopted by the Commission in 2007, and the undertaken impact assessment identified major policy challenges for organ donation and transplantation. These included:

  • ensuring the quality and safety of human organs
  • increasing organ availability
  • enhancing the efficiency and accessibility of transplantation systems in the EU

A public consultation demonstrated wide support for EU initiatives in this field.

In December 2008, the Commission adopted a proposal for a Directive that defines quality and safety requirements for human organs intended for transplantation, and an action plan  for improving co-operation between Member States in this field.

The directive on standards of quality and safety of human organs intended for transplantation was adopted by the European Parliament and the Council on 7 July 2010 (See Corrigendum to the Directive). It provides for the appointment of Competent Authorities in all Member States, for authorisation of procurement and transplantation centers and activities, for traceability systems, as well as for the reporting of serious adverse events and reactions. Moreover, the Directive will set requirements for the safe transportation of organs and for the characterisation of every donor and organ. Member States shall transpose the requirements of the Directive by 27 August 2012.

Medical applications

Legislation and guidelines 


Organisations and interest groups