Article R5211-31
…he manufacturer may instruct his authorised representative to initiate the following procedures: 1° Declaration relating to medical devices to be the subject of clinical investigations ; 2° EC declara…
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Showing 7201–7210 of 14413 articles for “Art. 6 Dec 1977”
…he manufacturer may instruct his authorised representative to initiate the following procedures: 1° Declaration relating to medical devices to be the subject of clinical investigations ; 2° EC declara…
…devices, the manufacturer follows the following procedures: 1° For class I medical devices, the EC declaration of conformity ; 2° For class II medical devices a choice of : a) the EC declaration of c…
…es the conformity of the devices with the technical documentation drawn up in application of the EC declaration of conformity procedure, and not with an EC type certificate, and with the essential req…
Where the conformity certification procedure applied by a manufacturer involves the intervention of an authorized body, the manufacturer may apply to the body of his choice within the framework of the…
The national cost studies referred to in Article L. 6113-11 may cover the following fields of activity:1° The activities mentioned in 1° of article R. 162-33 of the Social Security Code; 2° The activi…
…of the self-employed activities of statutory full-time practitioners as provided for in Article L. 6154-1.
…be granted to a health establishment meeting the conditions laid down in articles L. 1234-2 and L. 6122-2 if it has : 1° Full-time and part-time hospitalisation resources and an operating theatre ava…
The authorisation provided for in Article L. 6122-1 specifies : 1° The organ or organs for which it is granted ; 2° Whether the activity concerns children, adults and children or only adults; 3° The s…
The health care organisation authorised to carry out organ transplantation must be able to do so at any time. The health establishment authorised to carry out haematopoietic cell transplantation must…
The activity of organ transplants mentioned in 8° of article R. 6122-25 combines the surgical placement of an organ, several organs, part of an organ or the administration of cells from a living or de…
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