(ANSM) or the European Medicines Agency (EMA) before they can be used in accordance with the manufacturer’s recommendations; ∙active implantable MDs (such as microspheres labelled with yttrium-90) also require their manufacturer to apply the “CE” marking in order to be placed on the market in the member states or parties to the agreement with the European Economic Community in application of Directive 90/385/EEC transposed into the French Public Health Code in Articles R. 5211-1 to R. 5211-73. Pending the obtaining of an MA, and to allow early access to medicines for patients suffering from serious or rare diseases, derogation processes have proliferated in France over the last twenty years. In order to simplify and harmonise these different processes, a reform of the access to medicines by derogation was implemented on 1 July 2021 (Decree 2021-869 of 30 June 2021). This reform, which aims to “allow even faster access to these medicines for patients at a therapeutic dead-end”, replaces the six authorisation systems by two conditions of access, namely compassionate access and early access. The MDs emitting ionising radiation (electrical X-ray generators and particle accelerators, microspheres labelled with yttrium-90) used in nuclear-based medical activities must meet the essential requirements defined in the Public Health Code (Articles R. 5211‑23 and R. 5211‑23-1 for active implantable medical devices and R. 5211‑22 for the other medical devices). The “CE” marking, which certifies conformity with these essential requirements, is mandatory. Further to technological developments, the Order of 15 March 2010 laying down the essential requirements applicable to MDs other than active implantable devices (microspheres labelled with yttrium-90), was amended on 4 October 2019 to reinforce the provisions concerning the display of the dose during imaging procedures. Furthermore, European regulation EU 2017/745 of 5 April 2017 came into force on 26 May 2021. It has been amended by European regulation EU 2023/607 of 15 March 2023 which prolongs temporary provisions. Due in particular to the effects of the Covid-19 pandemic on companies and the as yet small number of organisations notified under the abovementioned regulation, these new provisions allow manufacturers who began a process for assessing the conformity of their MDs before 26 May 2024 under Regulation (EU) 2017/745 to continue, under certain conditions, putting these MDs on the market in accordance with Directive 90/385/EEC or Directive 93/42/EEC. The date beyond which it will no longer be possible to put on the market or put into service MDs emitting ionising radiation which do not comply with the abovementioned directives is set at 31 December 2028 at the latest, with the exception more specifically of iodine-125 seeds used in brachytherapy and yttrium-90-labelled microspheres mentioned above which must comply with Regulation (EU) 2017/745 by 31 December 2027 at the latest. 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 the competent authorities responsible for 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 is expected in 2025. 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 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. 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) 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 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 radio- logy will continue to come under the notification system. The French healthcare licensing system came into effect in June 2023. 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 Regional Health Agencies (ARS). The healthcare activities licence is a constituent of the application 214 ASN Report on the state of nuclear safety and radiation protection in France in 2024 Medical uses of ionising radiation
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