S.L. 483.1 Art. 6Traceability.

An establishment shall ensure that:

(a) 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;

(b) by means of a donor identification system a unique code is assigned to each donation and to each of the products associated with it;

(c) all tissues and cells are identified with a label that contains the information or references allowing a link to the information referred to in the schedules to these regulations and any amendments thereto; and

(d) the data necessary to ensure traceability at all stages is kept for a minimum of thirty years after clinical use. Data storage may also be in electronic form.