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Showing 1711–1720 of 6855 articles for “Art. EU Regulation 2016/1103”
…categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.
The performance study does not give rise to any direct or indirect financial compensation for the persons taking part, apart from the reimbursement of expenses incurred and, where applicable, compensa…
…ar: 1° The procedures applicable to the coordinated assessment procedure described in Article 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017; 2° The condi…
Performance studies relating to dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Performance studies relating to midwi…
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…
I.-For the duration of the performance study involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which ar…
…tic medical devices that are the subject of the performance study is punishable by a fine of 30,000 euros.
…pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article 60 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 and persons a…
Persons who are not affiliated to a social security scheme or who are beneficiaries of such a scheme may be asked to take part in performance studies which do not involve any risk or constraint and in…
…ng him. The information 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 pe…
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