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, called a 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, in particular, technical documentation enabling the design, manufacture, particularly where sterilization is concerned, and performance of the device to be understood. The manufacturer shall also make a type available to the authorised 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 part of the examination of the design of a device which incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product, with the exception of medicinal products derived from blood, and which may act on the human body by means of an action ancillary to that of the device, before taking its decision, the authorised body obtains the opinion of the Agence nationale de sécurité du médicament et des produits de santé, one of the competent authorities for medicinal products designated by the other Member States or parties to the Agreement on the European Economic Area or the European Medicines Agency. This opinion is included in the documentation concerning the device. The authorised body shall inform the authority consulted of its decision. Where the competent national authority consulted is the Agence nationale de sécurité du médicament et des produits de santé, its opinion shall be given within a maximum period of two hundred and ten days from receipt of complete documentation.
When examining the design of a device which incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product derived from blood, and which may act on the human body by means of an action ancillary to that of the device, the authorised body shall, prior to its decision, obtain the scientific opinion of the European Medicines Agency. This opinion is included in the documentation concerning the device. The authorised body may not issue the certificate if the European Medicines Agency's scientific opinion is unfavourable. It shall inform the Agency of its decision.
The manufacturer must inform the authorized body of any significant change made to the approved device or of any change in the case of an active implantable medical 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.
