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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 article 8 CELEX: 02004L0023-20090807 Traceability
1. Member States shall ensure that all tissues and cells procured, processed, stored or distributed on their territory can be traced from the donor to the recipient and vice versa. This traceability shall also apply to all relevant data relating to products and materials coming into contact with these tissues and cells. 2. Member States shall ensure the implementation of a donor identification system which assigns a unique code to each donation and to each of the products associated with it. 3. All tissues and cells must be identified with a label that contains the information or references allowing a link to the information referred to in Article 28(f) and (h). 4. Tissue establishments shall keep the data necessary to ensure traceability at all stages. Data required for full traceability shall be kept for a minimum of 30 years after clinical use. Data storage may also be in electronic form. |
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 article 8 CELEX: 02004L0023-20090807 5. The traceability requirements for tissues and cells, as well as for products and materials coming into contact with those tissues and cells and having an effect on their quality and safety, shall be adopted by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(3). 6. The procedures for ensuring traceability at Community level shall be established by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 29(3). |