European Union Organ Donation Directive 2010/53/EU (EUODD) requires the setting of quality and safety standards of organ donation and transplantation by a competent authority. This is enshrined in UK law by the first Statutory Instrument.
The commission Implementing Directive 2012/25/EU was introduced to set out rules for the transmission of information when organs are exchanged between Member States.
The requirements set out by the Directives have been enshrined into UK law through The Quality and Safety of Organs Intended for Transplantation Regulations 2012 and The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014.
These Statutory Instruments are the basis for the HTA Framework document (PDF). The Framework document contains detailed information on the mandatory regulatory requirements as well as guidance on how those requirements may be met. Where appropriate, the Framework document also signposts the reader to other relevant legislation, codes of practice and guidance.