In the tissue and haematopoietic and reproductive cells (MAR, Medically Assisted Reproduction) context, as defined by the European Directive 23/2004, Competent Authorities are organizations, designed by Member States, in charge of the implementation of quality and safety standards related to donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.
Quality standards, fixed by the European Directive 23/2004 and ratified or implemented by all Competent Authorities, ensure a high level of protection in case of human application.
Furthermore, every Member State has the faculty of appointing more than a competent authority responding to specific roles and spheres of competence and expertise (i.e.: a competent authority engaged in inspection procedures for tissue banks and another delegated to supervise procedures for tissues and cells procurement).
The functions of the Competent Authorities are the following:
- supervision of human tissue and cell procurement thanks to qualified personnel who oversees that all procedures respond to fixed quality criteria, as stated by art. 5, 2004/23/EC
- accreditation, designation, authorisation or licensing of tissue establishments and tissue and cell preparation processes, as stated by art. 6. 2004/23/EC
- inspections and control measures, as stated by art. 7, 2004/23/EC
- ensuring the traceability of all human tissues and cells, as stated by art. 8, 2004/23/EC
- management of import-export activity related to human tissues and cells from or to third countries are undertaken by tissue establishments under fixed quality, safety and traceability guidelines, as stated by art. 9, 2004/23/EC
- registration of all licensed tissue establishments and reporting obligations on their activity, as stated by art. 10, 2004/23/EC
- notification of serious adverse events and reactions, as stated by art.11, 2004/23/CE
According to European Directive 2004/23, which encourages Competent Authorities to publish every year an accessible register on their tissue establishments activity, Member States and the Commission decided to establish a network, namely Eurocet, to collect activity data from every Competent Authority and to provide a link between them.
