S.L. 483.6 Art. 10Traceability. Cap. 586.

(1) Procurement organisations and transplantation centres shall ensure that:

(a) all organs procured, allocated and transplanted on their territory can be traced from the donor to the recipient and vice versa in order to safeguard the health of donors and recipients;

(b) they have a donor and recipient identification system that can identify each donation and each of the organs and recipients associated with it.

(2) With regard to such a system, it shall be ensured that confidentiality and data security measures are in place in compliance with the provisions of the Data Protection Act.

(3) (a) The bodies involved in the chain from donation to transplantation or disposal shall keep the data needed to ensure traceability at all stages of the chain from donation to transplantation or disposal and the information on organ and donor characterisation as specified in the Schedule, in accordance with the framework for quality and safety.

(b) Data required for full traceability shall be kept for a minimum of thirty years after donation. Such data may be stored in electronic form.

(4) Where organs are exchanged between Member States, the procurement organisations and transplant centres shall transmit the necessary information to ensure the traceability of organs, in conformity with the procedures established by the European Commission pursuant to Article 29 of Directive 2010/53/EU.