Article R5212-28
I.-For the medical devices mentioned in article R. 5212-26, the operator is required :1° Keep a regularly updated inventory of the devices it operates, mentioning for each of them the common and comme…
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Showing 4371–4380 of 68984 articles for “Art. 222 al. 1 and al. 2”
I.-For the medical devices mentioned in article R. 5212-26, the operator is required :1° Keep a regularly updated inventory of the devices it operates, mentioning for each of them the common and comme…
…another Member State of the European Union or party to the Agreement on the European Economic Area and having been controlled by a laboratory designated for this purpose by that State. This inspectio…
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…
For the devices mentioned in Article R. 5212-26, with the exception of those used during exposure to ionising radiation, subject to internal or external quality control, the Director General of the Ag…
When informed of one of the events mentioned in Article L. 5212-2, the Director of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Med…
Manufacturers of medical devices and the companies and organisations operating these devices shall, at the reasoned request of the Director of the Agence nationale de sécurité du médicament et des pro…
Without prejudice to the obligations to provide information laid down by Article L. 5212-2 or by any other legislative or regulatory provision, the staff of the Agence nationale de sécurité du médicam…
…icament et des produits de santé, specifies the conditions under which these bodies are accredited, and in particular the guarantees of confidentiality, impartiality and independence of the quality co…
The rules of procedure are drawn up and adopted by the Strategic Committee, after consultation with the joint bodies and, in accordance with their respective remits, with the bodies of the institution…
For the application of articles R. 6331-52 and R. 6332-72 in Saint-Pierre-et-Miquelon, the words: "the body mentioned in article L. 225-1-1" are replaced by the words: "the social security fund mentio…
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