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 671–680 of 62812 articles for “Art. Futures margin and mark-to-market rules”
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…
The presentation, at scientific or technical meetings, exhibitions or demonstrations, of medical devices which do not comply with the provisions of this Title is authorised provided that a visible sig…
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…
…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 it. It must also be…
…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 whose use…
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.
The presentation at scientific or technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided…
…l 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 published in the Official Journa…
…ffixed 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 vitro diagnostic medical d…
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