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Showing 2021–2030 of 66562 articles for “Art. L. 239-1 to L. 239-5”
A decree of the Conseil d'Etat shall determine the conditions of application of this section.
…ty of performing arts entrepreneur without holding a valid activity declaration receipt as referred to in article L. 7122-3, or that it has not fulfilled the obligations set out in the third paragraph…
Before a clinical investigation is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this i…
…may only be carried out in a place that has the human, material and technical resources appropriate to the clinical investigation and compatible with the safety requirements of the persons undergoing…
…ion on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which are not minimal, the sponsor provides free of charge the medical devi…
…opinion on the conditions for the validity of the clinical investigation, particularly with regard to :the protection of individuals, in particular the protection of participants; -the adequacy, comp…
The clinical investigation does not give rise to any direct or indirect financial compensation for the persons who take part in it, apart from the reimbursement of expenses incurred and, where applica…
…of the assessment of the clinical investigation request provided for in Article 62(3) and referred to in Articles 70, 74, 75, 78 and 82 of this Regulation is the National Agency for the Safety of Med…
…ll the procedures are carried out and the products are used in the usual way, the dossier submitted to the Data Protection Committee and the competent authority must determine whether it is necessary…
…minor, this consent is expressed by each of the holders of parental authority. If it is impossible to consult one of the holders of parental authority, the clinical investigation may be carried out p…
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