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Showing 8541–8550 of 28624 articles for “Art. Cass. 1e civ. 30-6-2004 n° 1138”
The manufacturer who intends to have clinical investigations carried out in France to verify the performance of a medical device or to detect any undesirable side effects, or his authorised representa…
As part of the procedure applicable to medical devices undergoing clinical investigations, the manufacturer shall draw up a declaration containing the information referred to in Articles R. 1123-37 to…
Implantable medical devices, active implantable medical devices and class III devices must be subject to clinical investigations, unless the use of existing clinical data can be duly justified.
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the d…
…1 law no. 2015-366 of 31 March 2015 L. 1621-2 law no. 2002-276 of 27 February 2002 L. 1621-3La loi n° 2021-771 du 17 juin 2021 ratifiant les ordonnances n° 2021-45 du 20 janvier 2021 et n° 2021-71 du…
The following are punishable by two years' imprisonment and a fine of €30,000:1° Failure to prepare self-vaccines in compliance with the obligations set out in Article L. 5142-1-1;2° Failure to comply…
Subject to the adaptations provided for in this chapter, the following provisions shall apply to Saint-Martin in the wording resulting from decree no. 2020-1734 of 16 December 2020, unless otherwise s…
Subject to the adaptations provided for in this chapter, the following provisions shall apply to Saint-Barthélemy in the wording resulting from decree no. 2020-1734 of 16 December 2020, unless otherwi…
…it results from these derogations under the conditions laid down, as the case may be, by the décret n° 2000-815 du 25 août 2000 or the décret n° 2001-623 du 12 juillet 2001 or the décret n° 2002-9 du…
…t of the entries provided for in Article 769, is reproduced on bulletin no. 1. If not, the bulletin n° 1 is marked: "nil".
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