Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010... (32010L0053)
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Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation
- DIRECTIVE 2010/45/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- of 7 July 2010
- on standards of quality and safety of human organs intended for transplantation
- CHAPTER I
- SUBJECT MATTER, SCOPE AND DEFINITIONS
- Article 1
- Subject Matter
- Article 2
- Scope
- Article 3
- Definitions
- CHAPTER II
- THE QUALITY AND SAFETY OF ORGANS
- Article 4
- Framework for quality and safety
- Article 5
- Procurement organisations
- Article 6
- Organ procurement
- Article 7
- Organ and donor characterisation
- Article 8
- Transport of organs
- Article 9
- Transplantation centres
- Article 10
- Traceability
- Article 11
- Reporting system and management concerning serious adverse events and reactions
- Article 12
- Healthcare personnel
- CHAPTER III
- DONOR AND RECIPIENT PROTECTION AND DONOR SELECTION AND EVALUATION
- Article 13
- Principles governing organ donation
- Article 14
- Consent requirements
- Article 15
- Quality and safety aspects of living donation
- Article 16
- Protection of personal data, confidentiality and security of processing
- CHAPTER IV
- OBLIGATIONS OF COMPETENT AUTHORITIES AND EXCHANGE OF INFORMATION
- Article 17
- Designation and tasks of competent authorities
- Article 18
- Records and reports concerning procurement organisations and transplantation centres
- Article 19
- Exchange of information
- CHAPTER V
- ORGAN EXCHANGE WITH THIRD COUNTRIES AND EUROPEAN ORGAN EXCHANGE ORGANISATIONS
- Article 20
- Organ exchange with third countries
- Article 21
- European organ exchange organisations
- CHAPTER VI
- GENERAL PROVISIONS
- Article 22
- Reports concerning this Directive
- Article 23
- Penalties
- Article 24
- Adaptation of the Annex
- Article 25
- Exercise of the delegation
- Article 26
- Revocation of the delegation
- Article 27
- Objection to delegated acts
- Article 28
- Urgency procedure
- Article 29
- Implementing measures
- Article 30
- Committee
- Article 31
- Transposition
- CHAPTER VII
- FINAL PROVISIONS
- Article 32
- Entry into force
- Article 33
- Addressees
- ANNEX
- ORGAN AND DONOR CHARACTERISATION
- PART A
- Minimum data set
- Minimum data set
- PART B
- Complementary data set
- Complementary data set
- General data
- Donor data
- Donor medical history
- Physical and clinical data
- Laboratory parameters
- Image tests
- Therapy
- Statement of the European Parliament, the Council and the Commission on Article 290 TFEU
- Statement of the European Commission (Urgency)
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