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Showing 9631–9640 of 54001 articles for “Art. I-4°”
Any medical device placed on the market or put into service in France must bear the CE mark certifying that it meets the conditions set out in article R. 5211-17. However, CE marking is not required f…
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…
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…
On duly justified request, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may authorise, by way of derogation, the placing on the market and putting in…
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.
Approval is granted to legal entities only if the shareholders or members holding at least 25% of the votes, shares or voting rights and the managers meet the conditions set out in 3°, 4° and 5° of ar…
Any person practising orthoptics, within the meaning of article L. 4342-1, who does not hold a certificat de capacité d'orthoptiste or one of the diplomas or certificates of study in orthoptics establ…
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