CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Subject Matter
Article 1
This Directive lays down rules to ensure standards of quality and safety for human organs (hereinafter ‘organs’) intended for transplantation to the human body, in order to ensure a high level of human health protection.

Scope
Article 2
1
This Directive applies to the donation, testing, characterisation, procurement, preservation, transport and transplantation of organs intended for transplantation.
2
Where such organs are used for research purposes, this Directive only applies where they are intended for transplantation into the human body.

Definitions
Article 3
For the purposes of this Directive, the following definitions apply:
1. ‘authorisation’ means authorisation, accreditation, designation, licensing or registration, depending on the concepts used and the practices in place in each Member State;
2. ‘competent authority’ means an authority, body, organisation and/or institution responsible for implementing the requirements of this Directive;
3. ‘disposal’ means the final placement of an organ where it is not used for transplantation;
4. ‘donor’ means a person who donates one or several organs, whether donation occurs during lifetime or after death;
5. ‘donation’ means donating organs for transplantation;
6. ‘donor characterisation’ means the collection of the relevant information on the characteristics of the donor needed to evaluate his/her suitability for organ donation, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;
7. ‘European organ exchange organisation’ means a non-profit organisation, whether public or private, dedicated to national and cross-border organ exchange, in which the majority of its member countries are Member States;
8. ‘organ’ means a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy. A part of an organ is also considered to be an organ if its function is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;
9. ‘organ characterisation’ means the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;
10. ‘procurement’ means a process by which the donated organs become available;
11. ‘procurement organisation’ means a healthcare establishment, a team or a unit of a hospital, a person, or any other body which undertakes or coordinates the procurement of organs, and is authorised to do so by the competent authority under the regulatory framework in the Member State concerned;
12. ‘preservation’ means the use of chemical agents, alterations in environmental conditions or other means to prevent or retard biological or physical deterioration of organs from procurement to transplantation;
13. ‘recipient’ means a person who receives a transplant of an organ;
14. ‘serious adverse event’ means any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;
15. ‘serious adverse reaction’ means an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;
16. ‘operating procedures’ means written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end outcome;
17. ‘transplantation’ means a process intended to restore certain functions of the human body by transferring an organ from a donor to a recipient;
18. ‘transplantation centre’ means a healthcare establishment, a team or a unit of a hospital or any other body which undertakes the transplantation of organs and is authorised to do so by the competent authority under the regulatory framework in the Member State concerned;
19. ‘traceability’ means the ability to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, including the ability to:
  - identify the donor and the procurement organisation,
  - identify the recipient(s) at the transplantation centre(s), and
  - locate and identify all relevant non-personal information relating to products and materials coming into contact with that organ.