EU tissues and cells: Directive 2004/23/EC now, the SoHO Regulation from August 2027
The directive still applies through national law. From 7 Aug 2027 the SoHO Regulation takes over. Keep traceability tight through the change.
In Short
- Today your national implementing law applies.
- Trace every unit from donor to recipient and back.
- SoHO Regulation applies from 7 Aug 2027, some provisions later.
The Blood and Tissue Guide
Every unit identified. Every decision reviewed.
- Which rules reach your unit
- Receive, identify, quarantine
- Process, test, review
- Release, label, trace
Plus Evidence map and four worksheets.
Get the blood and tissue guideWe ask for your name and email so we can handle this request. The full guide then opens on this site, ready to translate, print or save. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.
UltimateFree guide
The Blood and Tissue Guide
Every unit identified. Every decision reviewed.
Directive 2004/23/EC sets EU quality and safety standards for human tissues and cells, implemented through national law. Regulation (EU) 2024/1938 on substances of human origin (SoHO) will repeal it and the blood directive, and the European Commission says it applies from 7 Aug 2027, with an extra year for certain provisions. This guide covers what tissue and cell establishments should do now. Checked against European Commission pages on 2 Oct 2026; the EUR-Lex text could not be opened from our tools.
Today: a directive through national law
Directive 2004/23/EC and its technical directives cover donation, procurement, testing, processing, preservation, storage and distribution. Because it is a directive, the rules you follow are your Member State's implementing law, and your competent authority licenses and inspects.
What applies now and from 2027
- LawDirective 2004/23/EC and technical directivesApplies now via national law
Quality and safety of tissues and cells.
- LawRegulation (EU) 2024/1938 (SoHO)Applies from 7 Aug 2027, some provisions later
Directly applicable; repeals 2002/98/EC and 2004/23/EC.
- GuidanceNational Competent Authority GuidanceVaries by Member State
Licensing, inspection and transition.
Traceability and the Single European Code
The technical directives require traceability from donor to recipient and back, and the Single European Code (SEC) for tissues and cells distributed for human application, with listed exemptions. Records must let you identify the donor, the establishment and every recipient facility.
Worked Example: Tracing a Graft
- DonationDonor D-7712 eligibility recorded and approvedMedical director
- ProcessingTwo grafts coded and linked to the donorProcessing lead
- DistributionGraft 1 to Hospital A; graft 2 storedDistribution
- AlertLate donor test result received; graft 2 quarantined, Hospital A informedQuality manager
- ReportQuality manager decides reportability and records whyQuality manager
Serious Adverse Events and Reactions
Establishments report serious adverse events and reactions to the competent authority under national procedures. People decide what is serious and reportable, and record why.
From August 2027: the SoHO Regulation
Regulation 2024/1938 applies directly, without national transposition, and widens scope to more substances of human origin. It introduces SoHO entities and establishments, donor and recipient protection rules and an EU SoHO Platform, a first version of which the Commission released on 15 Sep 2026.
More on from August 2027: the SoHO Regulation
Check national guidance for how your authority will move existing licences.
Records and who decides
Keep donor eligibility, testing, processing and storage records, codes and distribution records linked. V5's blood and tissue profile supports donor-eligibility records, ISBT 128 unit identifiers and storage monitoring with trace to the consignee.
More on records and who decides
People decide eligibility, release and reporting.
Questions
When does the SoHO Regulation apply?
The European Commission says Regulation (EU) 2024/1938 applies from 7 Aug 2027, with an extra year for certain provisions. Until then Directive 2004/23/EC applies through national law.
Does the SoHO Regulation replace national licensing?
It applies directly and harmonises more of the rules, but competent authorities in each Member State still authorise and inspect. Follow your national authority's transition guidance.
Is ISBT 128 the same as the Single European Code?
No. The SEC is the EU code for distributed tissues and cells. ISBT 128 is one coding system that can be used within it; check which coding your authority accepts.
Does V5 decide donor eligibility?
No. V5 records donor eligibility, unit identifiers, storage and distribution. Authorised people decide eligibility, release and reporting.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
21 CFR 1271 Readiness for Tissue and Cell Establishments
AABB Blood Bank Standards and 21 CFR 606 Readiness Guide
CAR T Cell Manufacturing Readiness: Chain of Identity and Release
Cord Blood Bank cGMP Readiness: 1271, BLA and FACT-NetCord
Donor Eligibility, Lookback and Deviation Readiness
FACT-JACIE Accreditation Readiness for Cell Therapy