EU Tissues and Cells Directives

E155010

EU health and safety legislation European Commission directive European Union directive European Union directive package

The EU Tissues and Cells Directives are a set of European Union laws that harmonize standards for the donation, testing, processing, storage, and distribution of human tissues and cells to ensure high levels of quality and safety across member states.

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All labels observed (9)

Label	Occurrences
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells	2
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells	1
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events, and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells	1
Directive 2004/23/EC on human tissues and cells	1
EU Tissues and Cells Directive	1
EU Tissues and Cells Directives canonical	1
Member States to designate competent authorities for tissues and cells	1
Member States to establish systems for traceability of tissues and cells	1
Tissues and Cells Directive 2004/23/EC	1

How this entity was disambiguated

This entity first appeared as the object of triple T1339573 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.

NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07

Target entity: EU Tissues and Cells Directives
Context triple: [Human Tissue Authority, hasLegalBasis, EU Tissues and Cells Directives]

A. Human Tissue Authority
The Human Tissue Authority is a UK regulatory body responsible for licensing and overseeing the removal, storage, use, and disposal of human bodies, organs, and tissue for purposes such as research, transplantation, and education.
B. NHS Blood and Transplant
NHS Blood and Transplant is a UK special health authority responsible for providing a safe and reliable supply of blood, organs, and associated services to the National Health Service.
C. European Union medical device regulations
European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
D. Cambridge Blood and Stem Cell Biobank
The Cambridge Blood and Stem Cell Biobank is a major research facility that collects, processes, and stores human blood and stem cell samples to support biomedical and translational research.
E. Committee for Advanced Therapies
The Committee for Advanced Therapies is a scientific body within the European Medicines Agency responsible for evaluating and providing expert opinions on advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies.
F. None of above. chosen
G. Unsure - the case is ambiguous/there is not enough information to decide.

NED2 Entity disambiguation (via description) gpt-5-mini-2025-08-07

Target entity: EU Tissues and Cells Directives
Target entity description: The EU Tissues and Cells Directives are a set of European Union laws that harmonize standards for the donation, testing, processing, storage, and distribution of human tissues and cells to ensure high levels of quality and safety across member states.

A. Human Tissue Authority
The Human Tissue Authority is a UK regulatory body responsible for licensing and overseeing the removal, storage, use, and disposal of human bodies, organs, and tissue for purposes such as research, transplantation, and education.
B. NHS Blood and Transplant
NHS Blood and Transplant is a UK special health authority responsible for providing a safe and reliable supply of blood, organs, and associated services to the National Health Service.
C. European Union medical device regulations
European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
D. Cambridge Blood and Stem Cell Biobank
The Cambridge Blood and Stem Cell Biobank is a major research facility that collects, processes, and stores human blood and stem cell samples to support biomedical and translational research.
E. Committee for Advanced Therapies
The Committee for Advanced Therapies is a scientific body within the European Medicines Agency responsible for evaluating and providing expert opinions on advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies.
F. None of above. chosen

Statements (48)

Predicate	Object
instanceOf	EU health and safety legislation ⓘ European Commission directive ⓘ European Commission directive ⓘ European Union directive ⓘ European Union directive package ⓘ
adoptedOn	2004-03-31 ⓘ 2006-02-08 ⓘ 2006-10-24 ⓘ
aimsTo	ensure high level of quality of human tissues and cells ⓘ ensure high level of safety of human tissues and cells ⓘ
allow	Member States to maintain or introduce more stringent protective measures ⓘ
appliesTo	European Union Member States ⓘ linked to: Member States of the European Union
covers	notification of serious adverse reactions and events ⓘ technical requirements for coding of human tissues and cells ⓘ technical requirements for distribution of human tissues and cells ⓘ technical requirements for donation of human tissues and cells ⓘ technical requirements for preservation of human tissues and cells ⓘ technical requirements for processing of human tissues and cells ⓘ technical requirements for procurement of human tissues and cells ⓘ technical requirements for storage of human tissues and cells ⓘ technical requirements for testing of human tissues and cells ⓘ traceability requirements for human tissues and cells ⓘ
doNotApplyTo	research using human tissues and cells that are not intended for application to the human body ⓘ
enteredIntoForce	2004-04-07 ⓘ
fullName	Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC as regards certain technical requirements for the donation, procurement and testing of human tissues and cells ⓘ linked to: EU Tissues and Cells Directives Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC as regards traceability requirements, notification of serious adverse reactions and events, and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells ⓘ linked to: EU Tissues and Cells Directives Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells ⓘ linked to: EU Tissues and Cells Directives
geographicalScope	European Economic Area ⓘ
implements	Directive 2004/23/EC ⓘ Directive 2004/23/EC ⓘ
includes	Directive 2004/23/EC ⓘ Directive 2006/17/EC ⓘ Directive 2006/86/EC ⓘ
influenced	national legislation on tissues and cells in EU Member States ⓘ
legalBasis	Article 152 of the EC Treaty ⓘ
policyArea	blood, tissues and cells regulation ⓘ public health ⓘ
regulates	distribution of human tissues and cells ⓘ donation of human tissues and cells ⓘ preservation of human tissues and cells ⓘ processing of human tissues and cells ⓘ storage of human tissues and cells ⓘ testing of human tissues and cells ⓘ
require	authorization of tissue establishments ⓘ quality management systems in tissue establishments ⓘ reporting of serious adverse reactions and events ⓘ traceability of tissues and cells from donor to recipient ⓘ
setsOut	general quality and safety standards for human tissues and cells ⓘ

How these facts were elicited

Referenced by (10)

Full triples — surface form annotated when it differs from this entity's canonical label.

Human Tissue Authority → hasLegalBasis → EU Tissues and Cells Directives ⓘ

Directive 2004/23/EC → fullName → Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells ⓘ

subject linked to: EU Tissues and Cells Directives