Directive 2010/53/EU

E624793

Directive 2010/53/EU is a European Union law that sets common standards for the quality and safety of human organs intended for transplantation across EU member states.

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Label Occurrences
Directive 2010/53/EU canonical 1

How this entity was disambiguated

Statements (46)

Predicate Object
instanceOf European Union directive
adoptedBy Council of the European Union NERFINISHED
European Parliament NERFINISHED
European Parliament and Council of the European Union NERFINISHED
aimsTo ensure a high level of human health protection in organ transplantation
facilitate cross‑border exchange of organs within the EU
set common quality and safety standards for human organs
appliesTo EU Member States NERFINISHED
concerns human organs intended for transplantation
contains provisions on data protection in the context of organ donation and transplantation
provisions on inspections and control measures by competent authorities
provisions on quality and safety requirements for organ characterisation
excludes tissues and cells regulated by Directive 2004/23/EC
geographicalScope European Union NERFINISHED
implementedBy national transposition measures of EU Member States
language binding in all official languages of the European Union
legalBasis Article 168 of the Treaty on the Functioning of the European Union NERFINISHED
legalNature binding legislative act
policyArea health and safety
organ transplantation
public health
principle non‑commercialisation of the human body and its parts
respect for donor and recipient anonymity, subject to national law
voluntary and unpaid organ donation
regulates donation of human organs for transplantation
preservation of human organs for transplantation
procurement of human organs for transplantation
testing of human organs for transplantation
transplantation of human organs
transport of human organs for transplantation
relationship complements national legislation on organ transplantation
forms part of the EU acquis in the field of health
requires authorization of organ procurement organisations and transplant centres
designation of competent authorities in each Member State
establishment of national quality programmes for organ donation and transplantation
information to donors and their families in accordance with national law
protection of deceased donors
protection of living donors
reporting and management of serious adverse events and reactions
systems for traceability of organs from donor to recipient and vice versa
training of personnel involved in organ donation and transplantation
scope quality and safety of human organs intended for transplantation
subjectMatter conditions for the donation, procurement, testing, preservation, transport and transplantation of human organs
reporting of serious adverse events and reactions related to organ transplantation
standards of quality and safety for human organs intended for transplantation
traceability of human organs

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Referenced by (1)

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

EU Organ Donation Directive shortName Directive 2010/53/EU