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Showing 4431–4440 of 13190 articles for “Art. professional status not enough”
…a statistical basis. In the latter case, if the procedure for checking the devices manufactured is not suitable for certain aspects, the manufacturer must, with the agreement of the approved body, es…
…comply with these common technical specifications. However, if, for duly justified reasons, they do not comply with these specifications, they must adopt solutions of at least an equivalent level to t…
The manufacturer may instruct his authorised representative to initiate the procedures mentioned in 1°, 2°, 4° and 5° of article R. 5221-19.
The conformity of in vitro diagnostic medical devices with the essential health and safety requirements is assessed by carrying out one or more of the following procedures: 1° The procedure applicable…
In vitro diagnostic medical devices, other than in vitro diagnostic medical devices undergoing performance evaluation, are classified in two categories: 1° In vitro diagnostic medical devices whose re…
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…
…es imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or for the devices referred to in Artic…
…al Journal of the European Union, of the authorised body which has been entrusted, in France or in another Member State of the European Union or party to the Agreement on the European Economic Area, w…
As part of the EC declaration of conformity procedure, the manufacturer shall draw up technical documentation making it possible to assess the conformity of the in vitro diagnostic medical device with…
An order of the Minister for Health, issued on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, specifies the conditions for applying th…
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