http://www.legislation.gov.uk/id/eudr/2006/17/contents

1.Deceased Donors 1.1.General criteria for exclusion 1.1.1.Cause of death unknown, unless autopsy provides information on the...1.1.2.History of a disease of unknown aetiology. 1.1.3.Presence, or previous history, of malignant disease, except for primary...1.1.4.Risk of transmission of diseases caused by prions. This risk...1.1.5.Systemic infection which is not controlled at the time of...1.1.6.History, clinical evidence, or laboratory evidence of HIV, acute or...1.1.7.History of chronic, systemic autoimmune disease that could have a...1.1.8.Indications that test results of donor blood samples will be...1.1.9.Evidence of any other risk factors for transmissible diseases on...1.1.10.Presence on the donor’s body of physical signs implying a...1.1.11.Ingestion of, or exposure to, a substance (such as cyanide,...1.1.12.Recent history of vaccination with a live attenuated virus where...1.1.13.Transplantation with xenografts. 1.2.Additional exclusion criteria for deceased child donors 1.2.1.Any children born from mothers with HIV infection or that...2.Living donors 2.1.Autologous living donor 2.1.1.If the removed tissues and cells are to be stored...2.2.Allogeneic living donor 2.2.1.Allogeneic living donors must be selected on the basis of...2.2.2.Selection criteria for allogeneic living donors must be established and...2.2.3.The same exclusion criteria must be applied as for deceased...

ANNEX IILABORATORY TESTS REQUIRED FOR DONORS (EXCEPT DONORS OF REPRODUCTIVE CELLS) AS REFERRED TO IN ARTICLE 4(1)

1.Biological tests required for donors 1.1.The following biological tests must be performed for all donors...1.2.HTLV-I antibody testing must be performed for donors living in,...1.3.When anti-HBc is positive and HBsAg is negative, further investigations...1.4.A validated testing algorithm must be applied to exclude the...1.5.In certain circumstances, additional testing may be required depending on...1.6.For autologous donors, Annex I, point 2.1.1, applies. 2.General requirements to be met for determining biological markers 2.1.The tests must be carried out by a qualified laboratory,...2.2.The biological tests will be carried out on the donor’s...2.3.When potential donors have lost blood and have recently received...2.4.In the case of a deceased donor, blood samples must...2.5.In the case of living donors (except allogeneic bone marrow...2.6.If in a living donor (except bone marrow stem-cell and...2.7.In the case of bone marrow and peripheral blood stem-cell...2.8.In the case of neonatal donors, the biological tests may...

ANNEX IIISELECTION CRITERIA AND LABORATORY TESTS REQUIRED FOR DONORS OF REPRODUCTIVE CELLS AS REFERRED TO IN ARTICLE 3(b) AND ARTICLE 4(2)

1.Partner donation for direct use 2.Partner donation (not direct use) 3.Donations other than by partners 4.General requirements to be met for determining biological markers 4.1.The tests must be carried out in accordance with Annex...4.2.For donations other than by partners, blood samples must be...4.3.Sperm donations other than by partners will be quarantined for...

ANNEX IVCELL AND/OR TISSUE DONATION AND PROCUREMENT PROCEDURES AND RECEPTION AT THE TISSUE ESTABLISHMENT AS REFERRED TO IN ARTICLE 5

1.Donation and procurement procedures 1.1.Consent and donor identification 1.1.1.Before the procurement of tissues and cells proceeds, an authorised...1.1.2.In the case of living donors, the health professional responsible...1.2.Donor evaluation (this section does not apply to partner donation...1.2.1.An authorised person must collect and record the donor’s relevant...1.2.2.In order to acquire the appropriate information, different relevant sources...1.2.3.In addition, in the case of a deceased donor, and...1.2.4.The complete donor records must be reviewed and assessed for...1.3.Procurement procedures for tissues and cells 1.3.1.The procurement procedures must be appropriate for the type of...1.3.2.The procurement procedures must protect those properties of the tissue/cells...1.3.3.For deceased donation, the area of access must be restricted....1.3.4.In the case of a deceased donor, the place of...1.3.5.Once the tissues and cells have been retrieved from a...1.3.6.Any adverse event occurring during procurement that has or may...1.3.7.Policies and procedures must be in place to minimise the...1.3.8.Sterile instruments and devices must be used for tissue and...1.3.9.When reusable instruments must be used, a validated cleaning and...1.3.10.Wherever possible, only CE marked medical devices must be used...1.4.Donor documentation 1.4.1.For each donor, there must be a record containing: 1.4.2.The organisation performing the procurement must produce a procurement report,...1.4.3.All the records must be clear and readable, protected from...1.4.4.Donor records required for full traceability must be kept for...1.5.Packaging 1.5.1.Following procurement, all recovered tissues and cells must be packaged...1.5.2.The packaged cells/tissues must be shipped in a container which...1.5.3.Any accompanying tissue or blood samples for testing must be...1.6.Labelling of the procured tissues/cells 1.7.Labelling of the shipping container 2.Reception of the tissue/cells at the tissue establishment 2.1.When the retrieved tissues/cells arrive at the tissue establishment, there...2.2.Each establishment must ensure that the tissue and cells received...2.3.Each tissue establishment must have a documented policy and specifications...2.4.The data that must be registered at the tissue establishment...2.5.In the case of reproductive cells intended for partner donation,...

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(a) thereof,

Having regard to 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 cells1, and in particular points (b), (d), (e), (f), and (i) of Article 28 thereof,

Whereas:

(1)

Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement and testing of all human tissues and cells intended for human applications, and of manufactured products derived from human tissues and cells intended for human applications, so as to ensure a high level of human health protection.

(2)

In order to prevent the transmission of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety, Directive 2004/23/EC calls for the establishment of specific technical requirements for each one of the steps in the human tissue and cell application process.

(3)

The use of tissues and cells for application in the human body carries a risk of disease transmission and other potential adverse effects in recipients. That risk can be reduced by careful donor selection, testing of each donation and the application of procedures to procure tissues and cells in accordance with rules and processes established and updated according to the best available scientific advice. Therefore, all tissues and cells, including those used as starting material for the manufacture of medicinal products, to be used in the Community should meet the quality and safety requirements laid down in this Directive.

(4)

Reproductive cells have, due to the specific nature of their application, specific quality and safety characteristics that are taken into account in this Directive.

(5)

For the donation of reproductive cells between partners that have an intimate physical relationship, it is justified to require less stringent biological testing, given that in this case the risk for the recipient is considered less than for donation from third parties. In order to minimise the risk of cross-contamination, biological testing of the donor will be necessary only when the donated cells will be processed, cultured or stored.

(6)

This Directive is based on international experience drawn upon through an extensive consultation, the Council of Europe’s Guide to safety and quality assurance for organs, tissues and cells, the European Convention on Human Rights, the Council of Europe’s Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo, 4.IV.1997), with its additional protocols, and recommendations from the World Health Organisation. In particular, with regard to further additional biological testing for donors originating from high-incidence areas of specific diseases or whose sexual partners or parents originate from high-incidence areas, Member States will refer to existing international scientific evidence. The Directive is consistent with the fundamental principles set out in the European Charter of Fundamental Rights.

(7)

The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2004/23/EC,

HAS ADOPTED THIS DIRECTIVE: