Subsection 2: General justification for categories of medical procedures using ionising radiation

I.-In application of 1° of Article L. 1333-2, each category of procedure is justified in general terms under the conditions laid down in Article R. 1333-47. These procedures are carried out when exposure to ionising radiation is of sufficient benefit to the health of the person concerned in relation to the risk it may present, taking into account the benefits to society and the potential exposure of professionals involved in…

I.-In liaison with healthcare professionals, the Minister for Health or the body designated by him draws up and distributes a guide defining the medical indications justifying procedures exposing patients to ionising radiation, in particular those most commonly used. It is updated periodically to take account of changes in techniques and practices and is distributed to those requesting and performing the procedures. This guide contains specific information for : 1° Procedures…

In the event of the use of a new technology intended for radiotherapy, radiosurgery, diagnosis or radioguided interventional practices, or of a new type of practice carried out using an existing technology, an order by the Minister for Health, issued after consultation with healthcare professionals and the opinion of the competent bodies, may lay down, on a transitional basis, special provisions for collecting and analysing information concerning the expected benefits…

At the end of the transitional period mentioned in Article R. 1333-48, the information collected and the results of its analysis are taken into account to update the guide provided for in Article R. 1333-47 and, in the case of diagnostic examinations and radioguided interventional practices, to establish diagnostic reference levels, in accordance with the provisions of Article R. 1333-61.

The provisions of Article R. 1333-48 apply : 1° To new radiopharmaceutical medicinal products benefiting from a marketing authorisation or an early access authorisation or a compassionate access authorisation mentioned in Article L. 5121-12 and II of Article L. 5121-12-1 ; 2° New radioactive implantable medical devices where this is justified by radiation protection issues.

Any organised screening programme involving exposure to ionising radiation is authorised by an order of the Minister for Health, issued after consultation with the Haute Autorité de Santé. This order specifies, where applicable, the technique used for this screening.