Article R5221-22
…l devices which are not included in the lists established by the order mentioned in Article R. 5221-6, the EC declaration of conformity; in the case of devices intended for self-diagnosis, the manufac…
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Showing 7661–7670 of 15170 articles for “Art. 6 mars 2013”
…l devices which are not included in the lists established by the order mentioned in Article R. 5221-6, the EC declaration of conformity; in the case of devices intended for self-diagnosis, the manufac…
The in vitro diagnostic medical devices referred to in Article L. 5221-5 may be exempted from conformity assessment procedures only if the procedure corresponding to the category of device does not in…
The provisions of articles R. 5211-25 to R. 5211-29 are applicable to in vitro diagnostic medical devices.
As part of the EC verification procedure, the manufacturer shall submit to an authorized body for inspection devices manufactured in conformity with an approved type as described in an EC type-examina…
The manufacturer may instruct his authorised representative to initiate the procedures mentioned in 1°, 2°, 4° and 5° of article R. 5221-19.
…aration of conformity, full quality assurance system; 4° EC type examination ; 5° EC verification ; 6° EC declaration of conformity, production quality assurance.
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…
An order of the Minister for Health, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, specifies the conditions for applying th…
I.-For the purposes of article L. 162-30-5 of the French Social Security Code, the following are considered to be exceptional: 1° A graft with rare medical indications which, in the indication in ques…
The authorisation shall specify: 1° The organs or tissues or vascularised tissues for which it is granted; 2° The indication or situation concerned; 3° Whether the activity concerns children, adults a…
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