The European Institute for Biomedical Imaging Research (EIBIR), in cooperation with the European Federation of Organisations for Medical Physics (EFOMP), EANM Research, Ltd. (EARL) and European Society of Radiology (ESR), is proud to have been awarded the European Commission Tender ‘SAMIRA Study on criteria for acceptability of medical radiological equipment’ (acronym: CARE).

The project began on 25 November 2024 and extends until 24 November 2026.

The project is led by Ms. Monika Hierath (EIBIR, AT), with scientific coordination by Dr. Marco Brambilla (EFOMP, IT) and aims to update the criteria for acceptability of medical radiological equipment, given change technological and regulatory changes in diagnostic radiology, nuclear medicine and radiotherapy since the 2012 publication of Radiation Protection Series N° 162.

Project objectives:

• Update existing criteria for acceptability in RP 162 in line with the current state of technical and equipment standards and methods for assessing relevant technical parameters and the latest modifications of the applicable Euratom and EU legal provisions
• Update and extend the criteria for acceptability to new types of equipment used in radiodiagnostic and radiotherapeutic procedures, interventional radiology, and other medical applications of ionising radiation for planning, guiding and verification purposes
• Identify equipment considered obsolete and remove the associated criteria for acceptability from the updated publication

Updating RP 162 is necessary to ensure it aligns with current standards and innovations and would be consistent with Council Directive 2013/59/Euratom, which in article 60, paragraph 2, mandates that Member States establish criteria for the acceptability of medical radiological equipment, indicating when intervention is required and including the removal of equipment from service. An updated RP 162 will ensure that the criteria reflect the latest technological capabilities and regulatory requirements, maintaining high standards of safety and effectiveness in medical radiological practices.

The project consortium consists of MPEs, as defined in article 4 of Council Directive 2013/59/Euratom, from the various clinical areas where ionising radiation is used. An Advisory Board will be formed to allow vital stakeholders not represented in the consortium, e.g., Member State competent authorities, the medical devices industry and standardisation organisations, to advise on the methodology and major outcomes of the study.

CARE consists of 5 work packages, which begin with a study of RP 162, review of literature on the development of acceptability criteria for medical radiological equipment and survey on national standards containing these criteria. These activities will provide the necessary input to update the publication, which will be evaluated in a consultation with Member State authorities, equipment manufacturers, standardisation bodies and other stakeholders before dissemination at a project workshop for further discussion.

Contact:

CARE is led by the European Institute for Biomedical Imaging Research.

ESR Office
Am Gestade 1
1010 Vienna, AT
Phone: +43 (1) 533 40 64 -20
E-mail: Monika Hierath, monika [.] hierath [@] myesr [.] org