Article R7232-8
…end of the approval period to the Prefect of the département in which the main establishment of the legal entity or sole trader is located. Each approved and certified organisation will automatically…
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Showing 3651–3660 of 12461 articles for “Art. legal committee”
…end of the approval period to the Prefect of the département in which the main establishment of the legal entity or sole trader is located. Each approved and certified organisation will automatically…
The authorisation issued to a legal entity or sole trader with several establishments may be modified if one of its establishments falls into one of the cases of withdrawal mentioned in article R. 723…
The application for authorisation must state : 1° The address and company name of the legal entity or the name of the sole trader ; 2° The address of the principal establishment of the legal entity or…
The approval decision is published in the prefecture's official journal of administrative acts. The prefect informs the body responsible for collecting social security contributions.
The declaration by the legal entity or sole trader, referred to in article L. 7232-1-1, is made to the prefect of the département where the legal entity's main establishment is located or where the so…
For the purposes of this Title, accessories to medical devices are treated as devices in their own right. Accessories are classified as such, independently of the devices with which they are used, wit…
In order to comply with the essential requirements relating to design and manufacture, active implantable medical devices must be designed, manufactured and packaged in such a way as to meet the follo…
Where a medical device is not intended for use in a specific part of the body, it must be considered and classified according to the most critical use as specified. Where more than one rule applies to…
In the event of a dispute over the application of the classification rules between the manufacturer of a device and an authorised body involved in the certification procedures provided for in this Tit…
…t accuracy and constancy of measurement taking into account their intended purpose and expressed in legal units; 5° Reduce the exposure of patients, users and third parties to emissions of radiation,…
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