Part five: Health products

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 to in vitro diagnostic medical devices undergoing an assessment of their performance ; 2° The EC declaration of conformity ; 3° The EC declaration of conformity, full quality assurance system; 4° EC type examination ; 5° EC verification ;…

The manufacturer may instruct his authorised representative to initiate the procedures mentioned in 1°, 2°, 4° and 5° of article R. 5221-19.

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 involve the intervention of an authorised body. Establishments providing care which manufacture these in vitro diagnostic medical devices in order to use them under the conditions provided for in Article L. 5221-5 are subject to the provisions of the…

For the purposes of placing on the market in vitro diagnostic medical devices other than those subject to a performance evaluation, manufacturers shall follow the following procedures: 1° For in vitro diagnostic medical 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 manufacturer may also follow one of…