Subsection 1: Operating conditions common to clinical and biological activities involving medically assisted procreation

Each health establishment, organisation, health cooperation group or medical biology laboratory authorised to carry out medically assisted procreation activities shall set up and keep up to date a quality assurance system. Documentation of the quality assurance system includes, in particular, validated procedures and operating methods.

The traceability of gametes for donation and embryos intended for reception is ensured by the use of the unique European donation code, the structure and allocation procedures for which are defined in the order mentioned in articles R. 2142-24 and R. 2142-27. This code is affixed to the traceability sheet accompanying the gametes and embryos concerned.

Health establishments and organisations authorised to carry out one or more biological activities in medically assisted procreation are responsible for : 1° Assigning the unique European donation code at the latest before gametes for donation and embryos intended for reception are made available; 2° affixing the unique European donation code on the traceability sheet and, where applicable, on the label of the gametes and embryos concerned; 3° Informing the Agence…

As part of the system relating to the single European donation code, the Agence de la biomédecine is responsible for : 1° allocating a unique establishment number to all health establishments and organisations authorised to carry out one or more biological activities for medically assisted procreation on national territory; 2° choosing the system or systems for allocating unique donation numbers used on national territory; 3° monitoring and implementing the system…

Traceability data is kept for forty years after gamete insemination, germ tissue transplant or embryo transfer.