French Public Health Code
In forceAs 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 include technical documentation enabling the design, manufacture and performance of the device to be understood. The manufacturer must also make a type available to the authorized body, which may request further copies as necessary.
The approved body checks that the type supplied has been manufactured in accordance with the documentation. It carries out or has carried out the examinations and tests necessary to verify that the solutions adopted by the manufacturer ensure compliance of the devices manufactured with the essential requirements. The place where these examinations and tests are carried out is agreed between the authorized body and the manufacturer.
Where the type meets the essential requirements, the authorised body issues the applicant with an EC type-examination certificate. A copy of this certificate may be obtained by the other approved bodies.
As soon as the manufacturer is aware of changes in the pathogens or markers of infection to be investigated, he must inform the authorised body without delay and state whether these changes are likely to affect the operation of the device.
The manufacturer must inform the authorised body of any changes made to the approved device. This modification must be approved by the authorized body if it may call into question the conformity of the device with the essential requirements mentioned or the conditions of use of the device.
