Regulation (EU) 2024/1938, known as the SoHO Regulation, repeals the EU Tissue and Cells Directive 2004/23/EC and the Blood Directive 2002/98/EC, and takes full effect from August 2027. For UK establishments the picture is not uniform: under the Windsor Framework the Regulation applies in Northern Ireland but not in Great Britain, so the two now sit on diverging regulatory tracks for the first time since the Directive was transposed. This paper sets out what the Regulation changes, where the UK position currently stands, and which traceability capabilities are worth confirming in your systems well ahead of 2027.
For two decades, the quality and safety framework for human tissues and cells across Europe rested on Directive 2004/23/EC and its two implementing directives, 2006/17/EC and 2006/86/EC. In the UK those requirements were transposed through the Human Tissue (Quality and Safety for Human Application) Regulations 2007, with the Human Tissue Authority (HTA) as competent authority. That framework is now being replaced.
Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application, the SoHO Regulation, entered into force in the European Union in August 2024. It repeals both Directive 2002/98/EC (blood and blood components) and Directive 2004/23/EC (tissues and cells), and takes full effect from August 2027 following a three-year transition period.
Two features of this change deserve attention from anyone responsible for traceability records. First, it is a Regulation rather than a Directive: it applies directly, without national transposition, which is precisely what makes the UK position more complicated rather than less. Second, it deliberately widens scope, moving from a fixed list of materials to an open definition of what counts as a substance of human origin, with technical guidance used to set specific standards so that the framework can keep pace with scientific developments.
This is the part most likely to be misunderstood, and it is worth stating plainly.
Under the Windsor Framework, the SoHO Regulation applies in Northern Ireland but not in Great Britain. Establishments in Northern Ireland will come under the Regulation as it takes effect. Establishments in England, Scotland and Wales continue to be regulated under the Human Tissue Act 2004 and the Q&S Regulations 2007, which retain the requirements originally derived from the Directive.
The HTA has begun work to implement the SoHO Regulation in Northern Ireland and to assess the implications for the establishments it regulates in Great Britain. The HTA describes this as running over multiple phases and concluding at the end of 2027, with the first phase determining the respective responsibilities of the HTA and of those it regulates. Establishments wanting to follow or contribute to that work can contact the HTA policy team.
Separately, the UK Government ran a call for evidence on a review of UK legislation for substances of human origin, which closed on 17 June 2026. The outcome of that review, rather than the EU Regulation itself, is what will determine the direction for Great Britain.
The practical consequence for a multi-site organisation is worth thinking through now. If you operate establishments on both sides of the Irish Sea, or you import from or export to the EU, you may find yourself running to two frameworks at once from 2027. Systems and standard operating procedures written on the assumption of a single common standard should be reviewed with that possibility in mind.
Compared with the Directives it replaces, the Regulation:
The traceability obligations will feel familiar in shape, which is good news for establishments that already run disciplined electronic records.
Retention. SoHO entities must keep the data necessary to ensure traceability, in electronic or paper form, for at least 30 years. The 30-year horizon that shaped record-keeping under the Directive therefore carries forward.
Coding. Where SoHO are donated by a third party, or moved between entities for within-relationship use, a code must be applied that is unique within the EU and does not reveal the identity of the person from whom the substances were collected. That code should be machine-readable unless the size of the material or its storage conditions make that impossible, and it should appear on the label or on accompanying documents where those documents can be guaranteed not to become separated from the material, or are kept digitally linked to it.
Two things follow from the coding requirement. The first is that machine-readable coding moves further from good practice towards default expectation, which matters if any part of your labelling is still handwritten or human-readable only. The second is the phrase "kept digitally linked", which is a recognition that the paper document travelling with the box is a weak link. An electronic record that holds the association between code, material and documentation is the more robust answer.
None of the following requires a decision about 2027 to be made today. All of it is worth confirming, because each item takes longer to fix than it does to check.
A purpose-built biological sample tracking system addresses these obligations as a by-product of ordinary work rather than as a separate compliance exercise. Barcode-driven handling makes coding machine-readable at every step by default. A complete audit trail records who did what, when, and what the previous value was, so donor-to-recipient traceability can be produced on demand rather than assembled. Documents, consent records and images attach to the sample record itself, which is what "digitally linked" means in practice. And structured electronic records are far easier to migrate across a thirty-year retention horizon than boxes of paper or a chain of spreadsheets.
What software cannot do is decide your regulatory position for you. The value of the next twelve months is in establishing which framework each of your establishments will sit under, and confirming that your records could satisfy either.
The SoHO Regulation is a significant change to a framework that has been stable for twenty years, and it arrives with an unusual wrinkle for the UK: Northern Ireland moves, Great Britain does not, and the Great Britain direction depends on a domestic review rather than on Brussels. August 2027 is far enough away that no establishment needs to act in haste, and close enough that the traceability questions above are worth answering while there is time to act on the answers.
This paper reflects the position as at July 2026. The HTA's implementation work runs to the end of 2027 and the UK review of SoHO legislation is ongoing, so establishments should treat the HTA's own guidance as the authority and watch for updates.
