Article 14
Traceability 1. Member States shall take all necessary measures in order to ensure that blood and blood components collected, tested, processed, stored, released and/or distributed on their territory can be traced from donor to recipient and vice versa. To this end, Member States shall ensure that blood establishments implement a system for identification of each single blood donation and each single blood unit and components thereof enabling full traceability to the donor as well as to the transfusion and the recipient thereof. The system must unmistakably identify each unique donation and type of blood component. This system shall be established in accordance with the requirements referred to in Article 29(a). With regard to blood and blood components imported from third countries, Member States shall ensure that the donor identification system to be implemented by blood establishments permits an equivalent level of traceability. 2. Member States shall take all necessary measures in order to ensure that the system used for the labelling of blood and blood components collected, tested, processed, stored, released and/or distributed on their territory complies with the identification system referred to in paragraph 1 and the labelling requirements listed in Annex III. 3. Data needed for full traceability in accordance with this Article shall be kept for at least 30 years.