Article R5221-18 of the French Public Health Code
November 1, 2023
The provisions of articles R. 5211-25 to R. 5211-29 are applicable to in vitro diagnostic medical devices.
The provisions of articles R. 5211-25 to R. 5211-29 are applicable to in vitro diagnostic medical devices.
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…
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 device and the assessment plan to be identified and certifying that the in vitro diagnostic medical devices comply with the provisions of this Title and the Orders made for its application which are applicable to them. The manufacturer undertakes to…
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 the essential requirements set out in Section 5 of this Chapter. He shall specify the principles for ensuring the quality of his production and guarantee that his manufacturing process complies with these principles. The manufacturer shall establish and maintain…
As part of the procedure for the EC declaration of conformity, a full quality assurance system, the manufacturer must submit to an approved body for verification the quality system which he has set up for the design, manufacture and testing of in vitro diagnostic medical devices and the application of which must guarantee compliance with the provisions of this Title and the implementing orders which apply to them. The manufacturer…
As part of the EC type-examination procedure, the manufacturer must submit to an authorized body for examination a representative sample, known as the type, of the production envisaged in order that the body may check that this sample satisfies the essential requirements defined in Section 5 of this Chapter which apply to the devices under consideration. The manufacturer must submit an application for assessment to an authorized body, which must…
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-examination certificate. The manufacturer must take all measures necessary to ensure that the manufacturing process guarantees conformity of the in vitro diagnostic medical devices manufactured with the type described in the EC type-examination certificate and with the essential requirements defined…
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is a Registered Trademark of
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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