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Showing 51–60 of 83 articles for “Art. 745”
For the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, the list of which is set by decision of the Director General of the Ag…
…cedure includes the supply of a custom-made device referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amendi…
…ects mentioned in Article L. 4211-1, sterile devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and experimental or ancillary medi…
…e the identification and traceability of the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amendi…
…the use of products intended for human health, products listed in Annex XVI of Regulation (EU) 2017/745 falling within its remit and products intended for cosmetic use. It monitors the risk associated…
I.-The clinical investigations of the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are governed by the provisions of the afo…
…te the medicinal products and devices referred to respectively in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and in Article 1 of Regulation (EU…
…of the European Parliament and of the Council of 16 April 2014, references to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and references to Regulation (EU)…
…of the European Parliament and of the Council of 16 April 2014, references to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and references to Regulation (EU)…
…devices and their accessories;3°a Non-medical products listed in Annex XVI to Regulation (EU) 2017/745;4° In vitro diagnostic medical devices and their accessories;5° Labile blood products;6° Organs,…
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