to MDs has been modified to reinforce the provisions concerning the display of the dose during imaging procedures. Moreover, the new European regulation EU 2017/745 entered into application on 26 May 2021 and its gradual implementation will mean that its requirements become applicable in full as of 27 May 2027 (after this date it will no longer be possible to put on the market or put into service MDs which do not comply with Council Directives 90/385/EEC and 93/42/EEC). This new European regulation reinforces patient safety on the one hand through a better clinical assessment of the MDs, and transparency on the other, thanks to the European Database on Medical Devices (EUDAMED). This database is accessible to the manufacturers and competent authorities alike, and partly accessible to the general public. 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 European competent authorities; ∙ 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) is working on the ZAP-X® gyroscopic stereotactic intracranial radiosurgery and radiotherapy platform, on the new radionuclides for nuclear medicine and on flash radiotherapy. It focused on two subjects in particular in 2023: ∙ the ZAP-X® gyroscopic platform manufactured by ZAP Surgical; ∙ flash radiotherapy. With regard to the ZAP-X® platform, in 2023 Canpri issued its opinion on the radiation protection of patients, workers, the fitting out of the rooms and the management of waste after use. Its opinion includes recommendations related to the preceding subjects intended for future users, manufacturers and institutions (Ministry of Health, HAS, ANSM, ASN, learned societies, etc.). ASN will issue a position statement on this basis in 2024. Canpri’s opinion on flash radiotherapy is expected in 2024. 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 abovementioned 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 particularly 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 ASN 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. Thus, since 1 July 2021, the ASN on-line services portal allows RNAs to register their activities. The list of medical activities subject to registration has been defined on the basis of the radiation protection risks (see Table 1 above) 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. Conventional radiology and dental radiology will continue to come under the notification system. The French healthcare licensing system came into effect in 2023. Healthcare facilities, physicians and legal entities involved in the area of health and wishing to develop a new healthcare activity or acquire or replace major medical equipment are now required to file a licence application with the Regional Health Agencies (ARS) in accordance with a calendar defined by the regional health schemes, which should extend over the next two years. The healthcare activities licence is a constituent of the application TABLE Classification of nuclear-based medical activities according to the radiation exposure risks ACTIVITIES PATIENTS PROFESSIONALS PUBLIC AND ENVIRONMENT External-beam radiotherapy 3 1 1 Brachytherapy 2 2 2 Internal targeted radiotherapy 3 2 3 Fluoroscopy-guided interventional practices 2 to 3 depending on the procedures 2 to 3 depending on the procedures 1 Diagnostic nuclear medicine 1 to 2 depending on the procedures 2 to 3 depending on the procedures 2 Computed tomography 2 1 1 Fluoroscopy-guided procedures on remote controlled table in radiology department 1 1 1 Conventional radiology 1 1 1 Dental radiology 1 1 1 1: no risk or low risk – 2: moderate risk – 3: high risk 1 ASN Report on the state of nuclear safety and radiation protection in France in 2023 209 • 07 • Medical uses of ionising radiation 07 05 15 08 11 04 14 06 13 AP 03 10 02 09 12 01
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