Justification of New Types or Classes of Practices In the Medical Field
The new Council Directive 2013/59/Euratom introduces the justificatioon of new types of practices in the medical field. Member States (MS) have until the 6th February 2018 to complete the process of transposition into their national regulations.
In 2014, HERCA decided to work on the justification of types or classes of practices (Articles 19 and 55.2 (a) and (c) Council Directive 2013/59/Euratom), whereby the focus is in particular on new types or classes of practices.
To further explore the transposition process of these articles, HERCA organised a Multi-Stakeholder Workshop (MSW) on Generic Justification of Medical Exposures using Ionising Radiation (24 – 26 October 2016, Montrouge, France).
In view of this workshop, the HERCA-Working Group Medical Applications (WGMA) prepared a discussion paper, which reflected the regulators’ perpectives. During the workshop, this document was extended and enriched by the stakeholders’ inputs and medical associations were invited to provide written comments. This work constitutes a commensurate input of the HERCA position paper on Justification of New Types or Classes of Practices In the Medical Field.
- HERCA PositionPaper GenJust [pdf - 1 MB]