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Showing 21–30 of 83 articles for “Art. 745”
…fromOrder no. 2022-582 of 20 April 2022, subject to replacing the reference to Regulation (EU) 2017/745 with the reference to the rules applicable in mainland France pursuant to Regulation (EU) 2017/7…
I.-The devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 shall be placed on the market or put into service in accordance with A…
Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submi…
The economic operators referred to in paragraph 35 of Article 2 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are required to register under the conditions…
…rom Order no. 2022-582 of 20 April 2022, subject to replacing the reference to Regulation (EU) 2017/745 with the reference to the rules applicable in mainland France under Regulation (EU) 2017/745 of…
…bent, under the vigilance exercised over the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the manufacturer or, where app…
…r. Where the competent authority considers that the requirements set out in Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 are not being met, it may at any t…
…listed in this section are medical devices within the meaning of Article 2 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices. The sp…
…applicable to the coordinated assessment procedure described in Article 78 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable to t…
…sécurité du médicament et des produits de santé, pursuant to Article 13(7) of Regulation (EU) 2017/745 or Article 14(4) of the same Regulation, that the device it has placed on the market, put into s…
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