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Showing 9231–9240 of 52230 articles for “Art. 1 oct. 2003”
The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…
…ance studies; -the methodology of the performance study with regard to the provisions of law no. 78-17 of 6 January 1978, as amended, relating to information technology, files and freedoms, the need t…
With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who volu…
…devices which are the subject of non-commercial performance studies under the following conditions: 1° In vitro diagnostic medical devices included on the list mentioned inarticle L. 165-1 of the Soci…
…ation shall be communicated in accordance with paragraphs 2 to 6 of Article 59 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017. Where the performance study co…
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…
…oper. Where the competent authority considers that the requirements set out in Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 are not being met, it may, at a…
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…
…nce study may be carried out provided that the other holder consents. The provisions of article 225-17 of the Criminal Code do not apply to these performance reviews.
…s 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 the Council of 5 April…
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