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Article R5211-41-1 of the French Public Health Code

For the purposes of the EC declaration of conformity procedure referred to in the first paragraph of Article R. 5211-40 and the EC type-examination procedure referred to in the first paragraph of Article R. 5211-41, in the case of a medical device or an active implantable medical device manufactured utilising tissues of animal origin referred to in Article R. 5211-23-1, the authorised body shall assess, in accordance with the procedures…

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Article R5211-42 of the French Public Health Code

As part of the EC verification procedure, the manufacturer submits the devices manufactured for inspection by an authorised body. The authorised body checks the conformity of the medical devices with an approved type described in an EC type-examination certificate referred to in Article R. 5211-41 or with the technical documentation referred to in Article R. 5211-39 under the conditions described in this sub-section. In addition, in the case of medical…

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Article R5211-43 of the French Public Health Code

In the case of active implantable medical devices or medical devices in Class III or Class II b, the manufacturer shall take all necessary measures to ensure that the manufacturing process guarantees conformity of the medical devices manufactured with the type described in the EC type-examination certificate and with the essential requirements defined in Section 5 of this Chapter which apply to them. He shall draw up technical documentation relating…

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Article R5211-44 of the French Public Health Code

For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-43 apply subject to the following modifications: 1° For class II a medical devices, the authorised body verifies the conformity of the devices with the technical documentation drawn up in application of the EC declaration of conformity procedure, and not with an EC type certificate, and with the essential requirements applicable to them. In the…

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Article R5211-45 of the French Public Health Code

As part of the EC declaration of conformity procedure, production quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the manufacture of his medical devices. The approved body shall verify that the application of this quality system ensures conformity of the devices with an approved type described in an EC type-examination certificate referred to in Article R. 5211-41…

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Article R5211-46 of the French Public Health Code

As part of the EC declaration of conformity procedure, production quality assurance, for active implantable medical devices or medical devices in class IIb or class III, the manufacturer submits an application to the authorised body for assessment of this quality system, which includes technical documentation setting out all the requirements and provisions adopted by the manufacturer for his quality system, particularly, where applicable, with regard to sterilisation. The manufacturer undertakes…

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Article R5211-47 of the French Public Health Code

For Class IIa medical devices or Class I medical devices, the provisions of Article R. 5211-46 apply subject to the following modifications: 1° For class II a medical devices, the authorised body verifies the conformity of the devices with the technical documentation drawn up in application of the EC declaration of conformity procedure and not with an EC type certificate, and with the essential requirements applicable to them. Similarly, the…

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Article R5211-48 of the French Public Health Code

As part of the EC declaration of conformity procedure, product quality assurance, the manufacturer shall submit to an authorised body for verification the quality system which he has set up for the final inspection of medical devices and in particular the appropriate tests relating thereto. The approved body shall verify that the application of this quality system ensures compliance of the devices with an approved type described in an EC…

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Article R5211-49 of the French Public Health Code

As part of the procedure for the EC declaration of conformity, product quality assurance, for class II b medical devices, the manufacturer must submit an application to the authorized body for assessment of the quality system relating to the final inspection and the associated tests. This application must include technical documentation setting out all the requirements and provisions adopted by the manufacturer for his quality system. The manufacturer undertakes to…

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Article R5211-50 of the French Public Health Code

Within the framework of the EC declaration of conformity procedure, product quality assurance, for class II a medical devices or class I medical devices, the provisions laid down in Article R. 5211-49 apply subject to the following modifications: 1° For class II a medical devices, the authorised body shall verify that the application of the quality system relating to the final inspection ensures the conformity of the devices inspected with…

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