Article R5211-47
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…
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Showing 6651–6660 of 47019 articles for “Art. L. 145-4”
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…
As part of the procedure for the EC declaration of conformity, a full quality assurance system, the manufacturer must submit to an approved body for verification the quality system which he has set up…
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…
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…
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…
Standby duty is paid at least once a year.
The service provider and the equipment distributor act in all circumstances in the interests of the person who is ill or has an incapacity or disability. They shall respect the dignity and privacy of…
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