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Showing 4191–4200 of 13190 articles for “Art. professional status not enough”
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 Arti…
…and certified either in France, in accordance with the procedures laid down in this chapter, or in another Member State of the European Union or party to the Agreement on the European Economic Area by…
…ise, by way of derogation, the placing on the market and putting into service of devices which have not undergone certification procedures, but whose use is of interest for the protection of health.
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 bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
The provisions of this Title apply to in vitro diagnostic medical devices as defined in Article L. 5221-1.
The provisions of Section 7 of Chapter I of Title I of this Book, with the exception of Article R. 5211-54, the second paragraph of Article R. 5211-55 and Articles R. 5211-55-1, R. 5211-62 and R. 5211…
…odified, supplemented, suspended, refused or cancelled; 4° the need for the competent authority of another Member State to intervene.
The approved body shall inform the other approved bodies in France or in the other Member States of the European Union or parties to the Agreement on the European Economic Area and which have been pub…
Where an in vitro diagnostic medical device forms an inseparable unit with a device which, if used separately, could be considered to be a medical device within the meaning of Article L. 5211-1 and wh…
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