Article R5211-14
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…
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Showing 1571–1580 of 4433 articles for “Art. 14 Dec 1989”
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…
Incidents or risks of incidents as defined in Article L. 5212-2 must be reported immediately.
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…
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.
…ts that are not reserved to the Board of Directors by virtue of article R. 5322-11. He prepares the decisions of the Board of Directors and ensures that they are implemented. He represents the agency…
In order to provide the most appropriate equipment for the needs of the person who is ill or has an incapacity or disability, the service provider and the equipment distributor will ask the prescriber…
…f information concerning nosocomial infections which must be reported in accordance with article R. 1413-79 is organised according to procedures defined by the institutional medical committee or the i…
…ult medical records or documents under the conditions laid down in the last paragraph of article L. 1414-4. If these conditions are not met, the files or documents in question shall be rendered anonym…
The location of the SMURs mentioned in 2° of article R. 6123-1 is determined by the regional health plan and ensures territorial coverage.
Attached to the contract are the health project, a list of agreements and other valid contracts signed by the holder with the regional health agency, and any financial agreements signed with bodies ot…
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