LES ACTIVITÉS NUCLÉAIRES : RAYONNEMENTS IONISANTS ET RISQUES POUR LA SANTÉ ET L’ENVIRONNEMENT monitoring the MD market; the general public has partial access to it. The aim of giving access to the information in this database is: ∙to help to improve the collaboration between: ‒the manufacturers or their representative and the competent authority of the country in which the MDs are manufactured/sold/ installed, ‒the competent European authorities responsible for monitoring the MD market; ∙to ensure greater public transparency, in particular by making available to the public the summary of the safety and clinical performance characteristic of each MD. To facilitate early access of patients to innovative and useful technologies which do not yet have the “CE” marking, the French National Authority for Health (HAS) has instituted an “innovation pass”. This innovation pass is a derogation and temporary mechanism put in place to facilitate early access of patients to innovative technologies (MDs) which are in the early phase of clinical development. The clinical study is conducted with the aim of confirming the human health benefit of the new technology. The clinical assessments conducted in order to put on the market MDs, RPDs, or for derogation processes allowing patients to receive an innovative treatment, are determining factors in the application of the justification principle (see point 1.3.4). To anticipate the radiation protection issues associated with the introduction of new techniques and emerging practices, the Committee for the Analysis of New Techniques and Practices using Ionising Radiation (Canpri – see chapter 2) was called upon in 2020 to work on the ZAP-X® gyroscopic stereotactic intracranial radiosurgery and radiotherapy platform. Canpri issued its opinion in 2023 on the radiation protection of patients, workers, the fitting out of the rooms and the management of waste after use. Its opinion includes recommendations intended for future users, manufacturers and institutions (Ministry of Health, HAS, ANSM, ASN, professional organisations, etc.). ASN issued a position statement on this basis on 22 October 2024 and published its opinion on its website (opinion 2024-AV-0447 of 22 October 2024). Canpri has also undertaken work on FLASH radiotherapy at the request of ASN since 2022. Its opinion was delivered in 2025 and will be the subject of a position statement by ASNR in 2026. 1.3.3 – Administrative system As part of the recasting of the classification of the different nuclear activities introduced by Decree 2018‑434 of 4 June 2018 stipulating diverse provisions in the nuclear field, ASN wanted to implement a more graded and proportionate approach to the risks. Three authorisation systems are now in place, namely licensing, notification and, since 1 July 2021, a simplified system called “registration”. Notification is a simple procedure which does not require the submission of any supporting documents. It is suited to the nuclear activities that present the lowest risks for workers, the public, patients and the environment. Licensing serves to regulate the activities presenting the greatest risks, for which ASNR checks, when examining the application file, that these risks have effectively been identified by the applicant and that the barriers intended to mitigate their effects are appropriate. This system is applicable to radiotherapy (including radiosurgery), brachytherapy and nuclear medicine for diagnostic and therapeutic purposes. Registration also involves the submission of documents for examination, but fewer in number. The list of medical activities subject to registration has been defined on the basis of the radiation protection risks (see Table 1) by ASN resolution 2021-DC-0704 of 4 February 2021. This system is applicable to computed tomography and to FGIPs, activities with radiation protection implications. Owing to the diversity of the “CBCT” devices and the particular radiation protection conditions associated with their use, these devices – with the exception of dental CBCTs – have also been placed under the registration administrative system in order to guarantee, in principle, better oversight of the radiation protection rules. Conventional radiology and dental radiology will continue to come under the notification system. In June 2023, the system for healthcare authorisations issued by the Regional Health Agency (ARS) came into force. Projects concerning the creation of any healthcare facility, the creation, conversion and grouping of healthcare activities, including in alternative forms to hospitalisation, and the installation of large medical devices are subject to the authorisation of the ARS. Among the changes stemming from the reform is the introduction of new healthcare activities, including interventional radiology and nuclear medicine and the reinforcing of the quality and safety approach with extension of the enforceability of the technical operating conditions of radiotherapy to neurosurgery departments. The healthcare activities and major medical equipment items will have to comply with the Installation Conditions (ICs – they detail the levels of the procedures in particular) set for each of them by the provisions of Chapter III of Title III of Book I of the 6th Part of the Public Health Code (Articles R. 6123-1 à R. 6123-212). These ICs are also associated with Technical Operating Conditions (TOCs – they include for example requirements concerning the composition of the teams, qualification of the personnel, fitting out of the rooms, patient follow-up methods, recourse to certain treatment methods, etc.). These TOCs are detailed by the provisions of Chapter IV of Title II of Book I of the 6th Part of the Public Health Code (Articles D. 6124-1 to D. 6124-501). The implementation of this reform will continue to modify existing legal structures and organisations. These changes may have consequences for continuity of care if they are not planned for in advance and a modification or even new license from ASNR may be required (change of RNA, drafting or modification of agreements, etc.). For example, in nuclear medicine certain devices may be shared between healthcare facilities; in external-beam radiotherapy, the radiosurgery activity may also be attached to a neurosurgery department. In nuclear medicine, two categories of department are distinguished: Category A departments, which do not perform therapeutic procedures, and Category B departments, which carry out, in particular, therapeutic procedures. In addition to the need to anticipate applications for licensing from the departments concerned, particularly in nuclear medicine where the ordering of radiopharmaceutical products depends on it, ASNR is particularly attentive to the impact of this reform on operational conditions for radiation protection, due to the organisational changes implemented. 1.3.4 – The particularities of patient radiation protection Justification and optimisation – The protection of patients undergoing medical imaging examinations or therapeutic procedures using ionising radiation is regulated by specific provisions of the Public Health Code (Articles R. 1333‑45 to R. 1333‑80). The principles of justification of the procedures and optimisation of the delivered doses constitute the cornerstone of this regulation. The principle of dose limitation does not apply to patients due to the need to adapt the delivered dose to the diagnostic or therapeutic end-purpose for each patient. ASNR ensures that this regulatory framework is updated through specific provisions with regard to optimisation, quality assurance, training and qualification as described below. The required qualifications – The use of ionising radiation on the human body is restricted to physicians and dental surgeons having the necessary skills to perform these procedures (Article R. 1333‑68 of the Public Health Code). To adapt the regulatory provisions to the technical changes and conditions of professional practice, ASN published resolution 2020-DC-0694 of 8 October 2020, approved by the Order of 5 July 2021, which came into effect in July 2021. It repeals 194 ASNR Report on the state of nuclear safety and radiation protection in France in 2025
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