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Showing 8761–8770 of 59890 articles for “Art. R 330-1”
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…
The presentation at scientific or technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided…
For the purposes of this chapter, army hospitals and the army blood transfusion centre are considered, respectively, as public health establishments and as a blood transfusion establishment. The local…
All manufacturers of in vitro diagnostic medical devices, or their representatives, shall appoint a person to be responsible for reactovigilance, whose identity and position shall be communicated to t…
Every manufacturer of medical devices, or its authorised representative, appoints a material vigilance correspondent and communicates his name to the Director General of the Agence nationale de sécuri…
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