Article R5141-121
The registers or records mentioned in articles R. 5141-118 to R. 5141-120 are kept for five years and must be produced whenever required by the competent authorities. The recording systems comply with…
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Showing 2281–2290 of 38550 articles for “Art. L 228-12”
The registers or records mentioned in articles R. 5141-118 to R. 5141-120 are kept for five years and must be produced whenever required by the competent authorities. The recording systems comply with…
A veterinary surgeon who prescribes medicinal products containing substances having an oestrogenic, androgenic or gestagenic action for farm animals shall record the following information in chronolog…
If, within a period of two years following notification of the authorisations provided for in articles R. 5142-8 to R. 5142-10, the establishment is not operating, these authorisations lapse. However,…
…or party to the Agreement on the European Economic Area when they are imported corresponds to a model laid down by decision of the Director General of the Agence nationale de sécurité sanitaire de l'a…
Any medical device placed on the market or put into service in France must bear the CE mark certifying that it meets the conditions set out in article R. 5211-17. However, CE marking is not required f…
User healthcare professionals not practising in one of the establishments mentioned in 4° of Article R. 5222-3 or in a blood transfusion establishment who are aware of incidents or risks of incidents…
Any health establishment or health cooperation group which uses or supplies medical devices or makes such devices available to its members, as well as any association distributing medical devices at h…
The CE marking is affixed under the responsibility of the manufacturer or his authorised representative, in a visible, legible and indelible manner on the in vitro diagnostic medical device where this…
The service provider and equipment distributor apply the advice on use and safety given by the equipment manufacturer. They provide the person who is ill or has an incapacity or disability and their f…
The provisions of this section do not prevent a health care establishment which is not authorised to carry out the activity mentioned in 3° of article R. 6123-1 from fulfilling its general obligations…
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