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Showing 9581–9590 of 60179 articles for “Art. R 145-29-1”
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail will notify the applicant of his decision within one hundred and twenty days from…
The CE mark is affixed under the responsibility of the manufacturer or his authorised representative. Its form and dimensions are laid down by order of the Minister for Health. The CE marking must be…
The affixing of marks or inscriptions on a medical device, on its packaging or on the instructions for use which are likely to mislead as to the meaning or form of the CE marking is prohibited. Any ot…
Where a medical device is not intended for use in a specific part of the body, it must be considered and classified according to the most critical use as specified. Where more than one rule applies to…
The presentation, at scientific or technical meetings, exhibitions or demonstrations, of medical devices which do not comply with the provisions of this Title is authorised provided that a visible sig…
Under the conditions laid down in article L. 5143-7, the regional prefect of the group's registered office approves the animal health programmes and grants approval to the groups mentioned in article…
In the event of a dispute over the application of the classification rules between the manufacturer of a device and an authorised body involved in the certification procedures provided for in this Tit…
The CE marking may be affixed to a medical device only if it complies with the essential health and safety requirements referred to in Section 5 of this Chapter and has undergone the certification pro…
Medical devices which comply with the standards applicable to them, transposing the harmonised European standards, the references of which have been published in the Journal officiel de la République…
On duly justified request, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may authorise, by way of derogation, the placing on the market and putting in…
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