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            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 cells (1), and in particular points (b), (d), (e), (f), and (i) of Article 28 thereof,

Whereas:

HAS ADOPTED THIS DIRECTIVE:

Article 1

Definitions

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

Article 2

Requirements for the procurement of human tissues and cells

1.   With the exception of partner donation of reproductive cells for direct use, Member States shall ensure that the procurement of human tissues and cells is accredited, designated, authorised or licensed only when the requirements in paragraphs 2 to 12 are met.

2.   Procurement of human tissues and cells shall be carried out by persons who have successfully completed a training programme specified by a clinical team specialising in the tissues and cells to be procured or a tissue establishment authorised for procurement.

3.   The tissue establishment or procurement organisation shall have written agreements with the staff or clinical teams responsible for donor selection, unless they are employed by the same organisation or establishment, specifying the procedures to be followed to assure compliance with the selection criteria for donors set out in Annex I.

4.   The tissue establishment or procurement organisation shall have written agreements with the staff or clinical teams responsible for tissue/cell procurement, unless they are employed by the same establishment or organisation, specifying the type(s) of tissues and/or cells and/or test samples to be procured and the protocols to be followed.

5.   There shall be standard operating procedures (SOPs) for the verification of:

There shall also be SOPs describing the procedures for procurement, packaging, labelling and transportation of the tissues and cells to the point of arrival at the tissue establishment or, in the case of direct distribution of tissues and cells, to the clinical team responsible for their application or, in the case of tissue/cell samples, to the laboratory for testing, in accordance with Article 5 of this Directive.

6.   Procurement shall take place in appropriate facilities, following procedures that minimise bacterial or other contamination of procured tissues and cells, in accordance with Article 5.

7.   Procurement materials and equipment shall be managed in accordance with the standards and specifications laid down in Annex IV, section 1.3, and with due regard to relevant national and international regulation, standards and guidelines covering the sterilisation of medicines and medical devices. Qualified, sterile instruments and procurement devices shall be used for tissue and cell procurement.

8.   Procurement of tissues and cells from living donors shall take place in an environment that ensures their health, safety and privacy.

9.   Where appropriate, the staff and equipment necessary for body reconstruction of deceased donors shall be provided. Such reconstruction shall be completed effectively.

10.   The procedures for the procurement of tissues and cells shall be carried out in accordance with the requirements specified in Article 5.

11.   A unique identifying code shall be allocated to the donor and the donated tissues and cells, during procurement or at the tissue establishment, to ensure proper identification of the donor and the traceability of all donated material. The coded data shall be entered in a register maintained for the purpose.

12.   Donor documentation shall be maintained in accordance with section 1.4 of Annex IV.

Article 3

Selection criteria for donors of tissues and cells

The competent authority or authorities shall ensure that donors comply with the selection criteria set out in:

Article 4

Laboratory tests required for donors

1.   The competent authority or authorities shall ensure that:

2.   The competent authority or authorities shall ensure that:

Article 5

Tissue and/or cell donation and procurement procedures and reception at the tissue establishment

The competent authority or authorities shall ensure that the tissue and/or cell donation and procurement procedures and the reception of tissues and/or cells at the tissue establishment comply with the requirements set out in Annex IV.

Article 6

Requirements for direct distribution to the recipient of specific tissues and cells

The competent authority or authorities may authorise the direct distribution of specific tissues and cells from where the procurement is carried out to a health care establishment for immediate transplantation.

Article 7

Transposition

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 November 2006, at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 8

Entry into force

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 9

Addressees

This Directive is addressed to the Member States.

Done at Brussels, 8 February 2006.

For the Commission

Markos KYPRIANOU            

Member of the Commission

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(1)OJ L 102, 7.4.2004, p. 48.

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ANNEX I

SELECTION CRITERIA FOR DONORS OF TISSUES AND/OR CELLS (EXCEPT DONORS OF REPRODUCTIVE CELLS) AS REFERRED TO IN ARTICLE 3(a)

Selection criteria for donors are based on an analysis of the risks related to the application of the specific cells/tissues. Indicators of these risks must be identified by physical examination, review of the medical and behavioural history, biological testing, post-mortem examination (for deceased donors) and any other appropriate investigation. Unless justified on the basis of a documented risk assessment approved by the responsible person as defined in Article 17 of Directive 2004/23/EC, donors must be excluded from donation if any of the following criteria applies:

1.   Deceased Donors

1.1.   General criteria for exclusion

1.2.   Additional exclusion criteria for deceased child donors

2.   Living donors

2.1.   Autologous living donor

2.2.   Allogeneic living donor

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ANNEX II

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

1.   Biological tests required for donors

2.   General requirements to be met for determining biological markers

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ANNEX III

SELECTION 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

Donor selection criteria and laboratory testing do not need to be applied in the case of partner donation of reproductive cells for direct use.

2.   Partner donation (not direct use)

Reproductive cells that are processed and/or stored and reproductive cells that will result in the cryopreservation of embryos must meet the following criteria:

3.   Donations other than by partners

The use of reproductive cells other than for partner donation must meet the following criteria:

4.   General requirements to be met for determining biological markers

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ANNEX IV

CELL 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

1.2.   Donor evaluation (this section does not apply to partner donation of reproductive cells or to autologous donors)

1.3.   Procurement procedures for tissues and cells

1.4.   Donor documentation

1.5.   Packaging

1.6.   Labelling of the procured tissues/cells

At the time of procurement, every package containing tissues and cells must be labelled. The primary tissue/cell container must indicate the donation identification or code and the type of tissues and cells. Where the size of the package permits, the following information must also be provided:

If any of the information under points (a) to (e) above cannot be included on the primary package label, it must be provided on a separate sheet accompanying the primary package.

1.7.   Labelling of the shipping container

When tissues/cells are shipped by an intermediary, every shipping container must be labelled at least with:

2.   Reception of the tissue/cells at the tissue establishment

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