Article R5211-15
The affixing of marks or inscriptions on a medical device, on its packaging or on the instructions for use which are likely to mislead as to the meaning or form of the CE marking is prohibited. Any ot…
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Showing 711–720 of 13025 articles for “Art. Euronext Harmonised Market Rules — derivatives”
The affixing of marks or inscriptions on a medical device, on its packaging or on the instructions for use which are likely to mislead as to the meaning or form of the CE marking is prohibited. Any ot…
…thorised provided that a visible sign clearly indicates that these devices may not be placed on the market or put into service until they have been brought into conformity.
The CE marking may be affixed to a medical device only if it complies with the essential health and safety requirements referred to in Section 5 of this Chapter and has undergone the certification pro…
Medical devices which comply with the standards applicable to them, transposing the harmonised European standards, the references of which have been published in the Journal officiel de la République…
No medical device may be placed on the market or put into service in France unless it complies with the essential health and safety requirements referred to in section 5 of this chapter which apply to…
…rité du médicament et des produits de santé may authorise, by way of derogation, the placing on the market and putting into service of devices which have not undergone certification procedures, but wh…
The labelling of a medical device given to the end user or patient, the accompanying leaflet and any other information relating to its operation or use must include a version written in French.
…participants and that a visible sign clearly indicates that these devices may not be placed on the market or put into service until they have been brought into compliance.
In vitro diagnostic medical devices appearing on the list established by the order referred to in Article R. 5221-6, designed and manufactured in accordance with common technical specifications publis…
The CE marking may be affixed to an in vitro diagnostic medical device only if it complies with the essential requirements and has undergone the assessment procedures applicable to it. Where an in vit…
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