The Director General of the Agence nationale de sécurité du médicament et des produits de santé may give formal notice to any operator of a medical device subject to the quality control provided for in this Title to have it carried out.
The resale of a second-hand medical device is understood to mean any transfer of a medical device which is neither new nor refurbished within the meaning of 2° of article R. 5211-4. The second-hand resale of any medical device on the list provided for in the third paragraph of article L. 5212-1 is subject to the prior issue of a certificate, under the conditions defined by this sub-section.
The provisions of this sub-section do not apply when: 1° The second-hand medical device is sold to a medical device manufacturer, as defined in 3° of Article R. 5211-4, unless the latter expressly requests this from the reseller; 2° The second-hand medical device comes from a Member State of the European Union or a party to the Agreement on the European Economic Area and complies with a technical rule that…
The certificate drawn up by the person responsible for the transfer of the second-hand medical device certifies that it has undergone regular maintenance in accordance with the provisions of article R. 5212-28 and, where the device is subject to internal or external quality control in application of article R. 5212-27, that its characteristics and performance comply with the acceptability criteria mentioned in 1° of this article. It mentions the information…
The certificate is accompanied by a file containing the following information: 1° The information contained in the register mentioned in 5° of article R. 5212-28 since the acquisition of the medical device by the person responsible for the transfer. When the device is subject to external quality control, the report relating to the maintenance of the performance of the medical device mentioned in article R. 5212-30 must be less than…
By way of derogation from the provisions of article R. 5212-35-4, where the second-hand medical device being transferred has never been put into service, the file is composed solely of the following elements: 1° The report of receipt of the medical device by the person responsible for the transfer, except where the transfer takes place before receipt of the device concerned; 2° A declaration on their honour by the person…
The certificate is issued by the person responsible for transferring the second-hand medical device to the transferee.
For medical devices, the list of which is set by order of the Minister for Health on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), material vigilance includes traceability rules from the time the medical devices are received in the healthcare or cosmetic surgery facility where they are…
The legal representative of health establishments, health cooperation groupings mentioned in article L. 6133-7 and cosmetic surgery establishments shall, after consulting the medical committee of the establishment mentioned inarticle L. 6144-2 or the medical conference of the establishment mentioned inarticle L. 6111-2, lay down the written procedure by which the data required for traceability is collected, stored and made accessible. This data is kept for a period of ten years….
The pharmacist in charge of managing the in-house pharmacy or, for establishments without an in-house pharmacy, the person in charge of ordering and managing stocks in the establishment, under the supervision of a healthcare professional, records all the data relating to the dispensing of medical devices on the list provided for in Article R. 5212-36. This record includes the following information: -the identification of each medical device: name, serial or…
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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
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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