Initiated by the European Commission (DG Energy) in 2011, the EU concluded the recast of five EURATOM Directives affecting equipment using ionizing radiation (wider industry coverage besides medical devices) by publishing on 17 January 2014, the Directive 2013/59/EURATOM, of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionizing radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom.
The European Union has also updated the Radiation Protection 91 (RP 91) published in 1997 (now named RP 162). This publication intends to facilitate the adoption by EU Member States of specific criteria of acceptability for equipment in order to indicate when appropriate remedial action is necessary, as required by Directive 97/43/Euratom. However, development of new radiological systems and technologies has created circumstances where the criteria of acceptability need to be reviewed to ensure the principles of justification and optimization are upheld.
COCIR created a dedicated Radiation TF. Our industry supported the merging of Directives 97/43/EURATOM and 96/29/EURATOM, as it will simplify the regulatory framework for the radiation protection in Europe.
COCIR is actively engaged with various stakeholders by responding to EC public consultations, developing position papers, giving high level presentations and bilateral meetings with key stakeholders at EU and national level to convey our members’ main messages to ensure the continuing safe use of these medical imaging modalities in the interest of EU healthcare system.