Article R5211-7
For the purposes of this Title, medical devices other than active implantable medical devices are divided into four classes known as Class I, Class IIa, Class IIb and Class III. Whether a device belon…
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Showing 4241–4250 of 41648 articles for “Art. L. 144-7”
For the purposes of this Title, medical devices other than active implantable medical devices are divided into four classes known as Class I, Class IIa, Class IIb and Class III. Whether a device belon…
In the event of disagreement on the application of the classification rules between the manufacturer of an in vitro diagnostic medical device and an authorised body involved in the conformity assessme…
The regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
Prescriptions for medical devices issued at the request of a patient with a view to obtaining a supply in another Member State of the European Union must include the following information: 1° The surn…
When the prescription includes the information provided for in 1°, subject to adaptation of the country information, to 3° of Article R. 5211-70, persons legally authorised to supply medical devices m…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision on prior authorisation within two months of the date of receip…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his prior authorisation decision within two months of the date of receipt o…
The duties of members of the Board of Directors are performed free of charge. Travel and accommodation expenses are reimbursed in accordance with the regulations applicable to civil servants.
When the person who is ill or who has an incapacity or disability is cared for by the multidisciplinary team, the service provider and the equipment distributor will cooperate with the members of this…
Persons receiving care in the establishment are informed by means of the welcome booklet or another written document:1° That data concerning them is processed automatically under the conditions laid d…
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