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…
For the purposes of placing a custom-made medical device on the market, the manufacturer shall follow the procedure defined in Article R. 5211-51. The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) may require the manufacturer of such devices to provide it with a list of the devices it has produced and…
The evaluation of the clinical data referred to in Article L. 5211-3-2, hereinafter referred to as the “clinical evaluation”, must, taking into account any relevant harmonised standards, follow a procedure based on either: -either a critical assessment of the relevant scientific literature currently available concerning the safety, performance, characteristics, design and intended purpose of the device, demonstrating the equivalence of the device with the device to which the data refer…
The clinical evaluation and its results are included or duly referenced in the technical documentation for the device referred to in Article R. 5211-39. The clinical evaluation and its documentation are updated using data obtained during post-marketing surveillance. The decision not to conduct clinical follow-up as part of the post-marketing surveillance plan for the device must be duly justified and documented.
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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