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Showing 41–50 of 83 articles for “Art. 745”
…t of medical devices and their accessories shall comply with the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and with the provisions of this Ti…
…s, distributors or importers of devices mentioned 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…
…dence from the evaluation of clinical data within the meaning of Article 61 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amendi…
I. - Advertising for the devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 means any form of information, including canvassing,…
…e or use of certain devices or categories of devices mentioned in Article 1 of Regulation (EU) 2017/745 is prohibited or regulated; 4° The arrangements for market surveillance of the same devices by t…
…c medical devices and their accessories;3° The products listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 ;4° (Repealed) ;5° Cosmetic produc…
…of human or animal origin are involved, which do not fall within the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 as defined in Article 1 thereof, o…
…iques and methods relating to the groups of products mentioned in Annex XVI of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amendi…
…€150,000: 1° Continuing, with regard to the devices mentioned in Article 1 of Regulation (EU) 2017/745, activities that have been the subject of one of the measures provided for in paragraph 4 of Art…
…n specifications or standards concerning the devices mentioned in Article 1 of Regulation (EU) 2017/745, transposing the harmonised European standards whose references have been published in the Journ…
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