Directive 2004/23/EC lays down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications, and of manufactured products derived from human tissues and cells intended for human applications, so as to ensure a high level of human health protection.

In order to prevent the transmission of diseases by human tissues and cells for human applications and to ensure an equivalent level of quality and safety, Directive 2004/23/EC calls for the establishment of specific technical requirements for each one of the steps in the human tissues and cells application process, including standards and specifications with regard to a quality system for tissue establishments.

An accreditation, designation, authorisation or licensing system for tissue establishments and for the preparation processes at the tissue establishments should be established in Member States in accordance with Directive 2004/23/EC, in order to ensure a high level of protection of human health. It is necessary to lay down the technical requirements for this system.

The requirements for accreditation, designation, authorisation or licensing of tissue establishments should cover the organisation and management, personnel, equipment and materials, facilities/premises, documentation and records and quality review. Accredited, designated, authorised or licensed tissue establishments should comply with additional requirements for the specific activities they carry out.

The air quality standard during the processing of tissues and cells is a key factor that may influence the risk of tissue or cell contamination. An air quality with particle counts and microbial colony counts equivalent to those of Grade A, as defined in the European Guide to Good Manufacturing Practice, Annex 1 and Commission Directive 2003/94/EC2, is generally required. However, in certain situations, an air quality with particle counts and microbial colony counts equivalent to those of Grade A standard is not indicated. In these circumstances it should be demonstrated and documented that the chosen environment achieves the quality and safety required for the type of tissue and cells, process and human application concerned.

The scope of this Directive should embrace the quality and safety of human tissues and cells during coding, processing, preservation, storage and distribution to the healthcare establishment where they will be applied to the human body. However, it should not extend to the human application of these tissues and cells (such as implantation surgery, perfusion, insemination or transfer of embryos). The provisions of this Directive concerning traceability and the reporting of serious adverse reactions and events apply also to the donation, procurement and testing of human tissues and cells regulated by Commission Directive 2006/17/EC3.

The use of tissues and cells for human application carries a risk of disease transmission and other potential adverse effects in recipients. In order to monitor and reduce these effects, specific requirements for traceability and a Community procedure for notifying serious adverse reactions and events should be set out.

Suspected serious adverse reactions, in the donor or in the recipient, and serious adverse events from donation to distribution of tissues and cells, which may influence the quality and safety of tissues and cells and which may be attributed to procurement (including donor evaluation and selection), testing, processing, preservation, storage and distribution of human tissues and cells should be notified without delay to the competent authority.

Serious adverse reactions may be detected during or following procurement in living donors or during or following human application. They should be reported to the associated tissue establishment for subsequent investigation and notification to the competent authority. This should not preclude a procurement organisation or an organisation responsible for human application from also directly notifying the competent authority if it so wishes. This Directive should define the minimum data needed for notification to the competent authority, without prejudice to the ability of Member States to maintain or introduce in their territory more stringent and protective measures which comply with the requirements of the Treaty.

In order to minimise transmission costs, avoid overlaps and increase administrative efficiency, modern technologies and e-government solutions should be used to perform the tasks related to the transmission and treatment of information. These technologies should be based on a standard exchange format using a system suitable for the management of reference data.

To facilitate traceability and information on the main characteristics and properties of tissues and cells, it is necessary to lay down the basic data to be included in a single European code.

This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union.

The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 29 of Directive 2004/23/EC,