The scope of application of this regulation includes the medical purpose in the definition of the medical devices and expands the new provisions to certain products with no medical purpose, for which the same safety requirements should apply owing to their operation and their risk profile. This new regulation notably organises improved regulation of the procedures for designating and monitoring notified organisations, which certify the conformity of medical devices, and sets a more restrictive framework for evaluations and clinical investigations for these products. It provides for an increase in the general requirements regarding safety and performance, as well as enhancement of the technical documentation, the implementation of traceability and identification of the medical devices. It also contains provisions on updating of the conformity evaluation procedures, improved information of the patient with regard to implantable devices and the medical devices entailing the highest risks, by providing the patient with an implant card or the publication of a summary of the safety and performance characteristics of these products. Finally, it organises the structuring and formalisation of European coordination by setting up a coordination group of competent authorities. The Ordinance adapts national law to these new rules, notably that applicable to the operators, from clinical evaluation up to monitoring of the medical devices market. DECREES AND ORDERS • Decree 2022-114 of 1 February 2022 relative to the technical conditions for operation of the nuclear medicine activity This Decree sets the technical operating conditions for diagnostic and therapeutic nuclear medicine activities. It creates a sub-section 17 concerning “nuclear medicine” after sub-section 16 of section 1 of Chapter IV of Title II of Book I of the sixth part of the Public Health Code. This new sub-section contains a certain number of obligations for the licensee of a category “B” nuclear medicine facility. These latter refer to the demarcation of an area with rooms dedicated to the administration of RadioPharmaceutical Drugs (RPD), patient recovery after the administration of RPD, the examinations performed after the administration of RPD, rooms for the preparation and reconstitution of RPD, RPD checks, cellular labelling of blood elements by one or more radionuclides, the storage of contaminated solid waste and radioactive effluents. Other provisions of this Decree concern the possession of certain equipment, appropriate initial and continuous training in radiopharmacy and radiation protection of personnel, patients, the public and the environment, but also the connection of an image and dose analysis archival and retrieval system. It also stipulates that the patient shall be informed of the dosimetric data concerning him or her. Finally, the license is subject to the quality assurance obligation. • Decree 2022-422 of 25 March 2022 relative to the environmental assessment of projects This Decree introduces a “safety net clause” in the environmental assessment procedure for those projects below the thresholds of the classification system of projects subject to the environmental assessment appended to Article R. 122-2 of the Environment Code: in the event of risks with notable impacts on the environment, these projects shall be examined on a case by case basis. The “safety net clause” does not concern projects for the creation, substantial modification or decommissioning of basic nuclear installations, which admittedly appear in the classification system of projects subject to the environmental assessment, but without thresholds. In practice, ASN – which is the competent authority responsible for the case by case examination of projects for notable modifications to Basic Nuclear Installations (BNIs), shall check that the project complies with the following principles: ∙ the question of the risk of notable negative impacts must be posed on receipt of any application for authorisation of a notable modification to a BNI, as set out in the second section of II of Article R. 122-2 of the Environment Code; ∙ in the more particular cases of creation or extension of Installations Classified for Protection of the Environment (ICPEs) within the perimeter of a BNI, the question of the risk of notable negative impacts should be posed, regardless of whether or not the project is below the thresholds appearing in the line concerning ICPEs in the classification system appended to Article R. 122-2 of the Environment Code. • Decree 2022-689 of 26 April 2022 relative to the layout conditions of the cancer treatment activity and Decree 2022693 of 26 April 2022 relative to the technical operating conditions of the cancer treatment activity These Decrees set out the conditions for the layout of cancer treatment activities (according to the procedures used in the activity concerned: oncological surgery, external radiotherapy, brachytherapy and systemic drug treatments for cancer), the conditions for licensing the activity and its renewal and the technical operating conditions for the cancer treatment activity (such as the organisation off a multi-disciplinary consultation meeting on significant changes in therapeutic orientations, provisions specific to minors and young adults, the definition of a multi-year training plan, or the conditions specific to oncological surgery, external radiotherapy, brachytherapy and systemic drug treatments for cancer). • Decree 2022-907 of 20 June 2022 relative to the local and inter-municipal safeguard plans, modifying the Domestic Security Code The purpose of this Decree is to define the procedures set out in the new Articles L. 731-3 and L. 731-4 of the Domestic Security Code regarding the Local Safeguard Plan (PCS) and the InterMunicipal Safeguard Plan (PICS). The aim is to specify the methods for producing and implementing these plans, in order to manage emergencies at all regional levels. The PCS is an overall organisational document for management of emergency situations affecting the population, according to their nature, their scale and how they develop. This plan prepares and ensures the operational response for protection and safeguard of the population. The PICS is an organisational document for the operational response at the inter-municipal level to deal with emergency situations, on behalf of the municipalities affected. It organises inter-municipal coordination and solidarity. ABSTRACTS – ASN Report on the state of nuclear safety and radiation protection in France in 2022 31 Regulatory News
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