Report from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on the standards of quality and safety of human organs intended for transplantation

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 lays down rules to ensure standards of quality and safety for human organs intended for transplantation into the human body, in order to ensure a high level of human health protection.

Article 7(1) of the Directive provides that organs and their donors must be characterised before transplantation through the collection of the information set out in the Annex to the Directive. Part A of the Annex lays down the minimum data set which has to be collected for each donation in accordance with Article 7. Part B of the Annex lays down the complementary data set data to be collected in addition, based on the decision of the medical team, taking into account the availability of such information and the particular circumstances of the case.

Article 24 of the Directive empowers the Commission to adopt, in accordance with the specified conditions, delegated acts in order to:
a) supplement or amend the minimum data set specified in Part A of the Annex only in exceptional situations where it is justified by a serious risk to human health considered as such on the basis of the scientific progress;
b) supplement or amend the complementary data set specified in Part B of the Annex in order to adapt it to scientific progress and international work carried out in the field of quality and safety of organs intended for transplantation.

The Commission has not yet used the delegated powers conferred by Article 24.

• Primary Source

EUR-Lex: COM(2015)123: Follow the progress of this report through the decision-making procedure http://eur-lex.europa.eu/legal-content/EN/HIS/?uri=COM:2015:123:FIN

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