Directive 2006/86 - Implementation of Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells - Main contents

EN

Official Journal of the European Union

L 294/32

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/EC (2), 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...