Statutory Instruments

The European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007

These Regulations give effect to Commission Directive 2006/86/EC of 24th October 2006. The Regulations may be cited as the European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007

The Regulations set down standards for 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.

The Regulations do not extend to the human application of these tissues and cells (such as implantation surgery, perfusion, insemination or transfer of embryos). The provisions in the Regulations concerning traceability and the reporting of serious adverse reactions and events also apply to the donation, procurement and testing of human tissues and cells

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