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Showing 2231–2240 of 65577 articles for “Art. s. L 227-1 to L 227-20-1”
Before a performance study is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this inform…
For each study of performance, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulatio…
Performance studies may only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the per…
…a deceased person in a state of brain death without his or her consent expressed during his or her lifetime or through the testimony of his or her family. However, where the deceased person is a mino…
…on a person without his or her free and informed consent, obtained in writing under the conditions laid down in paragraph 1 of Article 59 of Regulation (EU) 2017/746 of the European Parliament and of…
I.-The performance reviews of the devices referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 shall be governed by the provisions of the…
In accordance with article L. 253-1, the provisions of articles L. 631-1 to L. 631-4 and L. 632-1 to L. 632-7, are applicable to foreign nationals whose situation is governed by Book II.
Manufacturers of in vitro diagnostic medical devices may import or export tissues, their derivatives and cells from the human body, whatever their level of processing, when these products are intended…
A bulletin annexed to the Official Journal of the French Republic is hereby instituted under the title of Bulletin officiel des annonces civiles et commerciales.The Bulletin officiel des annonces civi…
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