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Showing 11331–11340 of 38939 articles for “Art. al. 4”
The provisions of articles R. 5211-15, R. 5211-17, R. 5211-19 and R. 5211-20 are applicable to in vitro diagnostic medical devices.
…hdrawn. The amount of the fine may not exceed the amount set in the second paragraph of article L. 5421-9. If the formal notice has not been acted upon by the end of the period set, the Director Gener…
…oned in 1°; 3° The results of internal quality controls carried out during the previous five years; 4° Documents relating to the maintenance of the in vitro diagnostic medical device since it was put…
Manufacturers who place in vitro diagnostic medical devices on the French market and who do not have their registered office on the territory of a Member State of the European Union or a party to the…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may give formal notice to any operator of a medical device subject to the quality control provided for i…
Manufacturers or their agents, importers and distributors shall declare without delay to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any incidents o…
At the end of the care or cosmetic surgery procedures using a medical device on the list provided for in article R. 5212-36, the patient is given a document stating:-the identification of the medical…
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…
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…
As part of the EC declaration of conformity procedure, the manufacturer shall draw up technical documentation making it possible to assess the conformity of the in vitro diagnostic medical device with…
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