The aspects of the new European Directive 2013/59/Euratom most relevant to diagnostic imaging and intervention are summarised. The Directive, laying down basic safety standards for protection against the dangers from exposure to ionising radiation, emphasises the need for justification of medical exposure (including asymptomatic individuals), introduces requirements concerning patient information and strengthens those for recording and reporting doses from radiological procedures, the use of diagnostic reference levels, the availability of dose-indicating devices and the improved role and support of the Medical Physics Experts in imaging. Relevant changes include new definitions, a new dose limit for the eye lens, non-medical imaging exposures, procedures in asymptomatic individuals, the use and regular review of diagnostic reference levels (including interventional procedures), dosimetric information in imaging systems and its transfer to the examination report, new requirements on responsibilities, the registry and analysis of accidental or unintended exposure and population dose evaluation (based on age and gender distribution). These changes will require Member States, the radiology community and the industry to adapt regulations, practices and equipment for a high standard of radiation safety. By 6 February 2018, the Directive has to be transposed into the national legislation of the Member States of the European Union.
• The new European Basic Safety Standards Directive impacts radiology departments
• Changes in justification, patient information, responsibilities and dose reporting are most significant
• Diagnostic reference levels and the role of medical physics experts are clarified
• Dose limits to the eye lens are lower than in the previous directive
• Responsibilities in radiation safety have been defined