Report on the implementation of Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation

Article 22 of Directive 2010/53/EU requires Member States to report to the European Commission, before 27 August 2013 and every three years thereafter, on the activities carried out in relation to the provisions of the Directive. The Commission is required to transmit a report on the implementation of this Directive to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

In 2013, several Member States were still in process of implementation; hence the Commission sent questionnaires to Member States in 2014 (implementation survey). This Report draws from the replies to this implementation survey, which was answered by 29 countries, all Member States and Norway. The analysis of these countries' replies to the 2014 implementation survey is included in the Staff Working Document accompanying this Report. Where appropriate, data gathered through other channels were also taken into account (e.g. exchanges with the national organ competent authorities during the bi-annual meetings with the Commission, Council of Europe annual Transplant Newsletters, Eurobarometer surveys and outputs of EU-funded projects).

This implementation report focuses on the institutional set-up in Member States, and in particular on the identification of the authorities in charge of the different tasks listed in Article 17 of Directive 2010/53/EU. The Annex to the Staff Working Document accompanying this Report sets out all authorities and their tasks. This report also makes some references to the Action Plan on Organ Donation and Transplantation, which complements Directive 2010/53/EU in improving quality and safety, and also focused on increasing organ availability and enhancing efficiency and accessibility of transplantation systems.

• Primary Source

EUR-Lex: SWD(2016)451: Commission Staff Working Document accompanying the report http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2016:451:FIN

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