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Showing 13391–13400 of 39711 articles for “Art. al. 3”
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…
The certificate drawn up by the person responsible for the second-hand resale certifies that the second-hand in vitro diagnostic medical device has been serviced as part of the accreditation referred…
…ich, under these regulations, bears the CE mark";h) Where applicable, the internal reference number;3° Does not include a statement to the effect that the medical device is reimbursed, in whole or in…
The resale of a second-hand medical device is understood to mean any transfer of a medical device which is neither new nor refurbished within the meaning of 2° of article R. 5211-4. The second-hand re…
For the application of the provisions of this chapter, army hospitals are considered to be public health establishments.
Any project to modify the elements mentioned in 1° and 2° of article R. 5213-5 is the subject of a new authorisation application submitted and examined under the same conditions as the initial authori…
Each user department of a medical device on the list provided for in Article R. 5212-36 completes the information mentioned in Article R. 5212-38 by recording:-the date of use ;the identification of t…
The approved body shall inform the other approved bodies in France or in the other Member States of the European Union or parties to the Agreement on the European Economic Area and which have been pub…
…nted ; 2° All decisions taken by the Director General under the procedures defined in this chapter; 3° All certificates issued, modified, supplemented, suspended, refused or cancelled; 4° the need for…
The provisions of Section 7 of Chapter I of Title I of this Book, with the exception of Article R. 5211-54, the second paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211…
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