Where the conformity certification procedure applied by a manufacturer involves the intervention of an authorized body, the manufacturer may apply to the body of his choice within the framework of the tasks for which that body has been authorized. Each procedure relating to a medical device may be the subject of an application to only one approved body.
The manufacturer or his authorised representative shall, for a period of at least five years and, in the case of implantable devices, at least fifteen years after the last copy of the product has been manufactured, keep at the disposal of the Director General of the Agence nationale de sécurité du médicament et des produits de santé the declarations of conformity and technical documentation which he has drawn up as…
The documents mentioned in article R. 5211-26 shall be presented by the manufacturer or his authorised representative at the request of the agents mentioned in article L. 5431-1.
In carrying out certification procedures, manufacturers and approved bodies shall take account of the available results of any assessment and verification operations which may have been carried out, pursuant to this Title, at an intermediate stage of manufacture.
Files and correspondence relating to certification procedures are drawn up in French or in a language of a Member State of the European Union or party to the Agreement on the European Economic Area accepted by the authorised body involved in the procedure.
For medical devices other than those subject to clinical investigations, the certification procedures mentioned in Article R. 5211-14 are as follows: 1° The EC declaration of conformity ; 2° The EC declaration of conformity, full quality assurance system ; 3° EC type-examination ; 4° EC verification; 5° EC declaration of conformity, production quality assurance ; 6° EC declaration of conformity, product quality assurance ; 7° The declaration relating to custom-made…
The manufacturer may instruct his authorised representative to initiate the following procedures: 1° Declaration relating to medical devices to be the subject of clinical investigations ; 2° EC declaration of conformity ; 3° EC type-examination ; 4° EC verification ; 5° Declaration relating to custom-made medical devices.
For medical devices to be subject to clinical investigations, the manufacturer must comply with the provisions of Title II of Book I of Part I of this Code.
For the purposes of placing active implantable medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the manufacturer shall follow the following procedures: 1° EC declaration of conformity, full quality assurance system ; 2° EC type examination, combined with EC verification; 3° EC type-examination, combined with EC declaration of conformity, production quality assurance.
For the purposes of placing medical devices other than active implantable medical devices on the market, with the exception of those undergoing clinical investigations and custom-made devices, the manufacturer follows the following procedures: 1° For class I medical devices, the EC declaration of conformity ; 2° For class II medical devices a choice of : a) the EC declaration of conformity, complete quality assurance system, with the exception of the…
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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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