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Showing 5041–5050 of 54326 articles for “Art. Art. R 224-2”
The Agence nationale de sécurité du médicament et des produits de santé submits to its control a sample of each batch of the substance which, if used separately from the medical device in which it is…
In application of Article L. 5212-1, the list of medical devices subject to compulsory maintenance, the list of medical devices subject to internal quality control and the list of medical devices subj…
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the d…
Where an in vitro diagnostic medical device forms an inseparable unit with a device which, if used separately, could be considered to be a medical device within the meaning of Article L. 5211-1 and wh…
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…
I.-External quality control of medical devices is carried out by bodies accredited for this purpose by the Comité français d'accréditation or by any other accreditation body which is a signatory to a…
As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, known as the type, of the production envisaged in order that t…
The Agency's inspectors shall carry out inspections as decided by the Agency's Director General, who shall issue a letter of assignment to the inspector in charge of the investigation. This letter spe…
On the basis of a contract that complies with good hospital pharmacy practice, the principles of which are laid down by order of the Minister for Health, and after obtaining the opinion of the regiona…
The safety of healthcare establishments in the event of a failure in the energy network is ensured under the conditions set out in sub-section 1 of section 4 of chapter II of title III of book VII of…
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