Human Tissue Authority

The regulator for human tissue and organs

Update on the implementation of the new European Union Directive

Issue date: 
28 July 2014

The new European Union Directive 2012/25/EU came into effect on Monday 14 July, following transposition into UK law via The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014. The Directive lays down information procedures for the exchange, between Member States, of human organs intended for transplantation. It outlines a detailed set of procedural rules for the transmission of information on human organs and donor characterisation, for the traceability of organs and for the reporting of serious adverse events and reactions.

The new legislation will not require any changes to current practices or procedures as the majority, if not all, of the activity relevant to this legislation is currently managed by the NHS Blood and Transplant (NHSBT). Following engagement with the NHSBT, the British Transplant Society, transplant clinicians and a private transplant hospital, we have updated the Quality and Safety of Organs Intended for Transplantation Framework document to reflect the new legislation. The newly inserted information can be found at paragraphs 92 to 110. 

A letter providing information on the new Directive was sent to all named contacts on ODT sector licences on Thursday 10 July.

If you have any questions about the new Directive please contact our enquiries team by telephoning 020 7269 1900 or emailing

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Last updated on: 1 Jul 2020