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 Article 5 of that Regulation and this Article. II.-Pursuant to Article 59 of this Regulation, the Agence nationale de sécurité du médicament et des produits de santé may, upon duly justified request, by way…
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 laid down in Article 31 of the same Regulation. In addition, the following are required to declare their activities to the Agence nationale de sécurité du médicament et des produits de santé, under conditions specified by…
The reprocessing of single-use devices referred to in Article 17 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, their placing on the market and their use are prohibited.
In the interests of public health, decrees issued by the Minister for Health shall, where necessary, lay down specific conditions relating to the supply of the devices referred to in article L. 5211-1.
I.-The criteria for classifying a situation as a risk in the management of a patient’s state of health due to the unavailability of a medical device shall be laid down by regulation. The manufacturers of the medical device or their authorised representatives or any person involved in its import or distribution, excluding retail sales, or, failing this, the Agence nationale de sécurité du médicament et des produits de santé, may…
The procedures for applying this Title, and in particular: 1° The procedures for filing and updating the declarations provided for in Article L. 5211-3-1 ; 2° The procedures for issuing medical devices prescribed in another Member State of the European Union and the procedures for prescribing medical devices with a view to issuing them in another Member State; 3° The conditions under which the sale, resale or use of certain…
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 Agence nationale de sécurité du médicament et des produits de santé, the operator is required to ensure that this performance and the maintenance of the medical device are maintained. This obligation gives rise,…
Certain medical devices for individual use appearing on a list drawn up by order of the ministers responsible for health and social security may be returned to a state of good repair with a view to re-use by patients other than those who initially used them. This return to good working order is subject to: 1° Compliance with criteria guaranteeing the quality and safety of use of the medical device…
The obligations of notification to the National Agency for the Safety of Medicines and Health Products or of information incumbent, 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 applicable, his authorised representative, the importer and the distributor, are defined by this Regulation, in particular in its…
For the devices mentioned in Article 1 of Regulation (EU) 2017/745, the list of which is set by order of the Minister responsible for health after receiving the opinion of the National Agency for the Safety of Medicines and Health Products, the health establishments mentioned in Article L. 6111-1 and the facilities mentioned in Article L. 6322-1 are required to fill in the registers created to monitor these devices. The…
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75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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