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Showing 4181–4190 of 12461 articles for “Art. legal committee”
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…
In vitro diagnostic medical devices appearing on the list established by the order referred to in Article R. 5221-6, designed and manufactured in accordance with common technical specifications publis…
The manufacturer may instruct his authorised representative to initiate the procedures mentioned in 1°, 2°, 4° and 5° of article R. 5221-19.
The conformity of in vitro diagnostic medical devices with the essential health and safety requirements is assessed by carrying out one or more of the following procedures: 1° The procedure applicable…
In vitro diagnostic medical devices, other than in vitro diagnostic medical devices undergoing performance evaluation, are classified in two categories: 1° In vitro diagnostic medical devices whose re…
…ovisions. If these provisions allow the manufacturer, during a transitional period, to choose which legal system he applies, the CE marking indicates that the device complies only with the regulations…
All in vitro diagnostic medical devices imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or…
The CE marking is affixed under the responsibility of the manufacturer or his authorised representative, in a visible, legible and indelible manner on the in vitro diagnostic medical device where this…
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