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Showing 6121–6130 of 24328 articles for “Art. 4 oct. 1994”
…ith an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under the conditions descri…
…s, the dissemination of advertising which is manifestly contrary to the provisions of articles R. 5141-82 to R. 5141-88.
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-46 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body veri…
…devices and send it the batch release certificate for the substance referred to in Article R. 5212-24 used in this device, drawn up by the Agence nationale de sécurité du médicament et des produits de…
As part of the procedure for the EC declaration of conformity, product quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessm…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall carry out his duties relating to reactovigilance under the conditions defined in Article R. 5311-2…
For the application of the provisions of this chapter, army hospitals are considered to be public health establishments.
The medical file referred to in article R. 1112-2 must include:identification of the medical device: name, serial or batch number, name of the manufacturer or its authorised representative; - date of…
Doctors and dental surgeons who use medical devices on the list provided for in Article R. 5212-36, who carry out their activity outside a health or cosmetic surgery establishment, record the data nec…
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