Evaluation of national actions regarding the transposition of Council Directive 2013/59/Euratom’s requirements in the medical sector
The new Basic Safety Standards Directive (Council Directive 2013/59/Euratom) modernises European radiation protection legislation by taking account of the latest scientific knowledge, technological progress, and operational experience with current legislation. At the same time, the new BSS consolidates the existing acquis of Euratom radiation protection legislation into one single piece of legislation, merging five Directives and upgrading a recommendation to become legally binding. As a result of the consolidation process, the new BSS Directive was given a broader scope and a completely new structure improving coherence and clarity of both definitions and requirements.
The new Directive entails substantial new requirements in various topical areas, e.g. improving the protection of patients in medical applications, improving the protection of workers, and improving the protection of the public in particular from natural radiation sources.
After entry into force of the Directive 2013/59/Euratom on 6 February 2014, Member States will have four years (i.e. 6 February 2018) to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.
The Commission is aware that the transposition and implementation of this comprehensive piece of legislation will constitute a major challenge for the respective national legislators and regulators in European Union Member States, Candidate States, and EFTA States. Therefore, the Commission approved this 15-month tender project in May 2016 to monitor the transposition of the BSS Directive into Member States‘ national legislation and to support its implementation.
The objective of this EC tender project was to evaluate Member States‘ activities for the transposition and implementation of Council Directive 2013/59/Euratom in the medical area. In addition, Candidate and EFTA States were contacted to help facilitate the detection of issues, an exchange of first experiences and resolutions, and the identification of good practices.
This project was awarded to a consortium headed by the European Federation of Organisations for Medical Physics (EFOMP). Other participating organisations were the European Society of Radiology (ESR) and the European Federation of Radiographer Societies (EFRS).
The Executive Summary of the final report is available for download here.
Project Manager: Ms. Monika Hierath (ESR), monika [.] hierath [@] myesr [.] org
This project has received funding from the European Commission under Service Contract No° ENER/16/NUCL/SI2.730592.