1.Member States shall designate a competent authority to carry out tasks in accordance with this Directive. They shall ensure that the competent authority:
(a)is functionally separate from any other body or organisation concerned with the promotion or utilisation of practices under this Directive, in order to ensure effective independence from undue influence on its regulatory function;
(b)is given the legal powers and human and financial resources necessary to fulfil its obligations.
2.Where a Member State has more than one competent authority for a given area of competence, it shall designate one point of contact for communication with the competent authorities of other Member States. Where it is not reasonably practicable to list all such points of contact for different areas of competence, Member States may designate a single point of contact.
3.Member States shall forward to the Commission the name and address of the points of contact and their respective areas of competence to enable rapid communication, where appropriate, with their authorities.
4.Member States shall forward to the Commission any changes to the information referred to in paragraph 3.
5.The Commission shall communicate the information referred to in paragraphs 3 and 4 to all points of contact in a Member State and shall publish it periodically in the Official Journal of the European Union, at intervals of no more than two years.
Member States shall ensure that information in relation to the justification of classes or types of practices, the regulation of radiation sources and of radiation protection is made available to undertakings, workers, members of the public, as well as patients and other individuals subject to medical exposure. This obligation includes ensuring that the competent authority provides information within its fields of competence. Information shall be made available in accordance with national legislation and international obligations, provided that this does not jeopardise other interests such as, inter alia, security, recognised in national legislation or international obligations.
1.Member States shall ensure that any undertaking acquiring equipment containing radioactive sources or a radiation generator is provided with adequate information about its potential radiological hazards and its proper use, testing and maintenance, and with a demonstration that the design permits to restrict exposures to a level which is as low as reasonably achievable.
2.Member States shall ensure that any undertaking acquiring medical radiological equipment is provided with adequate information on the risk assessment for patients, and on the available elements of the clinical evaluation.
1.Member States shall ensure that arrangements are in place for the recognition of:
(a)occupational health services;
(b)dosimetry services;
(c)radiation protection experts;
(d)medical physics experts.
Member States shall ensure that the necessary arrangements are in place to ensure the continuity of expertise of these services and experts.
If appropriate, Member States may establish the arrangements for the recognition of radiation protection officers.
2.Member States shall specify the recognition requirements and communicate them to the Commission.
3.The Commission shall make the information received in accordance with paragraph 2 available to the Member States.
Member State shall ensure that occupational health services perform medical surveillance of exposed workers, in accordance with Chapter VI, with regard to their exposure to ionising radiation and their fitness for the tasks assigned to them involving work with ionising radiation.
Member State shall ensure that dosimetry services determine internal or external doses to exposed workers subject to individual monitoring, in order to record the dose in cooperation with the undertaking and in the case of outside workers, the employer, and where relevant the occupational health service.
1.Member State shall ensure that the radiation protection expert gives competent advice to the undertaking on matters relating to compliance with applicable legal requirements, in respect of occupational and public exposure.
2.The advice of the radiation protection expert shall cover, where relevant, but not be limited to, the following:
(a)optimisation and establishment of appropriate dose constraints;
(b)plans for new installations and the acceptance into service of new or modified radiation sources in relation to any engineering controls, design features, safety features and warning devices relevant to radiation protection;
(c)categorisation of controlled and supervised areas;
(d)classification of workers;
(e)workplace and individual monitoring programmes and related personal dosimetry;
(f)appropriate radiation monitoring instrumentation;
(g)quality assurance;
(h)environmental monitoring programme;
(i)arrangements for radioactive waste management;
(j)arrangements for prevention of accidents and incidents;
(k)preparedness and response in emergency exposure situations;
(l)training and retraining programmes for exposed workers;
(m)investigation and analysis of accidents and incidents and appropriate remedial actions;
(n)employment conditions for pregnant and breastfeeding workers;
(o)preparation of appropriate documentation such as prior risk assessments and written procedures;
3.The radiation protection expert shall, where appropriate, liaise with the medical physics expert.
4.The radiation protection expert may be assigned, if provided for in national legislation, the tasks of radiation protection of workers and members of the public.
1.Member States shall require the medical physics expert to act or give specialist advice, as appropriate, on matters relating to radiation physics for implementing the requirements set out in Chapter VII and in point (c) of Article 22(4) of this Directive.
2.Member States shall ensure that depending on the medical radiological practice, the medical physics expert takes responsibility for dosimetry, including physical measurements for evaluation of the dose delivered to the patient and other individuals subject to medical exposure, give advice on medical radiological equipment, and contribute in particular to the following:
(a)optimisation of the radiation protection of patients and other individuals subject to medical exposure, including the application and use of diagnostic reference levels;
(b)the definition and performance of quality assurance of the medical radiological equipment;
(c)acceptance testing of medical radiological equipment;
(d)the preparation of technical specifications for medical radiological equipment and installation design;
(e)the surveillance of the medical radiological installations;
(f)the analysis of events involving, or potentially involving, accidental or unintended medical exposures;
(g)the selection of equipment required to perform radiation protection measurements;
(h)the training of practitioners and other staff in relevant aspects of radiation protection;
3.The medical physics expert shall, where appropriate, liaise with the radiation protection expert.
1.Member States shall decide in which practices the designation of a radiation protection officer is necessary to supervise or to perform radiation protection tasks within an undertaking. Member States shall require undertakings to provide the radiation protection officers with the means necessary for them to carry out their tasks. The radiation protection officer shall report directly to the undertaking. Member States may require employers of outside workers to designate a radiation protection officer as necessary to supervise or perform relevant radiation protection tasks as they relate to the protection of their workers.
2.Depending on the nature of the practice, the tasks of the radiation protection officer in assisting the undertaking, may include the following:
(a)ensuring that work with radiation is carried out in accordance with the requirements of any specified procedures or local rules;
(b)supervise implementation of the programme for workplace monitoring;
(c)maintaining adequate records of all radiation sources;
(d)carrying out periodic assessments of the condition of the relevant safety and warning systems;
(e)supervise implementation of the personal monitoring programme;
(f)supervise implementation of the health surveillance programme;
(g)providing new workers with an appropriate introduction to local rules and procedures;
(h)giving advice and comments on work plans;
(i)establishing work plans;
(j)providing reports to the local management;
(k)participating in the arrangements for prevention, preparedness and response for emergency exposure situations;
(l)information and training of exposed workers;
(m)liaising with the radiation protection expert.
3.The task of the radiation protection officer may be carried out by a radiation protection unit established within an undertaking or by a radiation protection expert.