Search Legislation

Directive 2010/53/EU of the European Parliament and of the CouncilShow full title

Directive 2010/53/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

 Help about what version

What Version

Close

This is a legislation item that originated from the EU

After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.

The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.

Status:

EU Directives are being published on this site to aid cross referencing from UK legislation. After exit day no further amendments will be applied to this version.

  1. Introductory Text

  2. CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

    1. Article 1.Subject Matter

    2. Article 2.Scope

    3. Article 3.Definitions

  3. CHAPTER II THE QUALITY AND SAFETY OF ORGANS

    1. Article 4.Framework for quality and safety

    2. Article 5.Procurement organisations

    3. Article 6.Organ procurement

    4. Article 7.Organ and donor characterisation

    5. Article 8.Transport of organs

    6. Article 9.Transplantation centres

    7. Article 10.Traceability

    8. Article 11.Reporting system and management concerning serious adverse events and reactions

    9. Article 12.Healthcare personnel

  4. CHAPTER III DONOR AND RECIPIENT PROTECTION AND DONOR SELECTION AND EVALUATION

    1. Article 13.Principles governing organ donation

    2. Article 14.Consent requirements

    3. Article 15.Quality and safety aspects of living donation

    4. Article 16.Protection of personal data, confidentiality and security of processing

  5. CHAPTER IV OBLIGATIONS OF COMPETENT AUTHORITIES AND EXCHANGE OF INFORMATION

    1. Article 17.Designation and tasks of competent authorities

    2. Article 18.Records and reports concerning procurement organisations and transplantation centres

    3. Article 19.Exchange of information

  6. CHAPTER V ORGAN EXCHANGE WITH THIRD COUNTRIES AND EUROPEAN ORGAN EXCHANGE ORGANISATIONS

    1. Article 20.Organ exchange with third countries

    2. Article 21.European organ exchange organisations

  7. CHAPTER VI GENERAL PROVISIONS

    1. Article 22.Reports concerning this Directive

    2. Article 23.Penalties

    3. Article 24.Adaptation of the Annex

    4. Article 25.Exercise of the delegation

    5. Article 26.Revocation of the delegation

    6. Article 27.Objection to delegated acts

    7. Article 28.Urgency procedure

    8. Article 29.Implementing measures

    9. Article 30.Committee

    10. Article 31.Transposition

  8. CHAPTER VII FINAL PROVISIONS

    1. Article 32.Entry into force

    2. Article 33.Addressees

    1. ANNEX

      ORGAN AND DONOR CHARACTERISATION

      1. PART A Minimum data set

        1. Minimum data set

      2. PART B Complementary data set

        1. Complementary data set

          1. General data

          2. Donor data

          3. Donor medical history

          4. Physical and clinical data

          5. Laboratory parameters

          6. Image tests

          7. Therapy

  9. ATTACHMENTS

    1. Statement of the European Parliament, the Council and the Commission on Article 290 TFEU

    2. Statement of the European Commission (Urgency)

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.

For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources