Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation

• Published date: 06 August 2010
• Official Gazette Publication: Gazzetta ufficiale dell’Unione europea, L 207, 06 agosto 2010,Diario Oficial de la Unión Europea, L 207, 06 de agosto de 2010,Journal officiel de l’Union européenne, L 207, 06 août 2010

2010L0053 — EN — 06.08.2010 — 000.001

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►B DIRECTIVE 2010/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207 6.8.2010, p. 14)

Corrected by:

►C1 Corrigendum, OJ L 243, 16.9.2010, p. 68 (2010/45/EU)

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▼B

▼C1

DIRECTIVE 2010/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 7 July 2010

▼B

on standards of quality and safety of human organs intended for transplantation

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject Matter

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.

Article 2

Scope

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.

Article 3

Definitions

For the purposes of this Directive, the following definitions apply:

(a) ‘authorisation’ means authorisation, accreditation, designation, licensing or registration, depending on the concepts used and the practices in place in each Member State;

(b) ‘competent authority’ means an authority, body, organisation and/or institution responsible for implementing the requirements of this Directive;

(c) ‘disposal’ means the final placement of an organ where it is not used for transplantation;

(d) ‘donor’ means a person who donates one or several organs, whether donation occurs during lifetime or after death;

(e) ‘donation’ means donating organs for transplantation;

(f) ‘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;

(g) ‘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;

(h) ‘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;

(i) ‘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;

(j) ‘procurement’ means a process by which the donated organs become available;

(k) ‘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;

(l) ‘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;

(m) ‘recipient’ means a person who receives a transplant of an organ;

(n) ‘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;

(o) ‘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;

(p) ‘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;

(q) ‘transplantation’ means a process intended to restore certain functions of the human body by transferring an organ from a donor to a recipient;

(r) ‘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;

(s) ‘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.

CHAPTER II

THE QUALITY AND SAFETY OF ORGANS

Article 4

Framework for quality and safety

1. Member States shall ensure that a framework for quality and safety is established to cover all stages of the chain from donation to transplantation or disposal, in compliance with the rules laid down in this Directive.

2. The framework for quality and safety shall provide for the adoption and implementation of operating procedures for:

(a) the verification of donor identity;

(b) the verification of the details of the donor's or the donor's family's consent, authorisation or absence of any objection, in accordance with the national rules that apply where donation and procurement take place;

(c) the verification of the completion of the organ and donor characterisation in accordance with Article 7 and the Annex;

(d) the procurement, preservation, packaging and labelling of organs in accordance with Articles 5, 6 and 8;

(e) the transportation of organs in accordance with Article 8;

(f) ensuring traceability, in accordance with Article 10, guaranteeing compliance with the Union and national provisions on the protection of personal data and confidentiality;

(g) the accurate, rapid and verifiable reporting of serious adverse events and reactions in accordance with Article 11(1);

(h) the management of serious adverse events and reactions in accordance with Article 11(2).

The operating procedures referred to in points (f), (g) and (h) shall specify, inter alia, the responsibilities of procurement organisations, European organ exchange organisations and transplantation centres.

3. In addition, the framework for quality and safety shall ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal are suitably qualified or trained and competent, and shall develop specific training programmes for such personnel.

Article 5

Procurement organisations

1. Member States shall ensure that the procurement takes place in, or is carried out by, procurement organisations that comply with the rules laid down in this Directive.

2. Member States shall, upon the request of the Commission or another Member State, provide information on the national requirements for the authorisation of procurement organisations.

Article 6

Organ procurement

1. Member States shall ensure that medical activities in procurement organisations, such as donor selection and evaluation, are performed under the advice and the guidance of a doctor of medicine as referred to in Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications ( 7 ).

2. Member States shall ensure that procurement takes place in operating theatres, which are designed, constructed, maintained and operated in accordance with adequate standards and best medical practices so as to ensure the quality and safety of the organs procured.

3. Member States shall ensure that procurement material and equipment are managed in accordance with relevant Union, international and national legislation, standards and guidelines on the sterilisation of medical devices.

Article 7

Organ and donor characterisation

1. Member States shall ensure that all procured organs and donors thereof are characterised before transplantation through the collection of the information set out in the Annex.

The information specified in Part A of the Annex contains a set of minimum data which has to be collected for each donation. Information specified in Part B of the Annex contains a set of complementary data to be collected in addition, based on the decision of the medical team, taking into account the availability of such information and the particular circumstances of the case.

2. Notwithstanding paragraph 1, if according to a risk-benefit analysis in a particular case, including in life-threatening emergencies, the expected...