Article R5222-18-1
The resale of a second-hand in vitro diagnostic medical device means any transfer of a medical device that is neither new nor refurbished within the meaning of 6° of Article R. 5221-4. The second-hand…
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Showing 1361–1370 of 26507 articles for “Art. Loi n° 2014-626 du 18 juin 2014”
The resale of a second-hand in vitro diagnostic medical device means any transfer of a medical device that is neither new nor refurbished within the meaning of 6° of Article R. 5221-4. The second-hand…
The certificate drawn up by the person responsible for the second-hand resale certifies that the second-hand in vitro diagnostic medical device has been serviced as part of the accreditation referred…
The certificate is issued by the person responsible for transferring the second-hand medical device to the transferee.
The provisions of this section do not apply when : 1° The device is sold to a manufacturer of an in vitro diagnostic medical device, except where the latter expressly requests this from the reseller;…
…1° The results of the quality controls mentioned in articles L. 6221-9 and L. 6221-10, carried out during the previous five years, where they related to the in vitro diagnostic medical device that is…
…holder has on site : electro-physiotherapy equipment ; -a balneotherapy facility or a body weight reduction system. II - The authorisation holder provides access, on site or by agreement, to -a worksh…
…e or on call of a doctor with proven training in paediatric and congenital cardiology; 4° For the "adult ischaemic and structural heart disease" modality, the presence on site or on call of a doctor s…
…archiving and sharing images in order to improve the quality of care and the relevance of the procedures performed. The holder of the authorisation, with the exception of holders of the authorisation…
I.-An interventional procedure under medical imaging in cardiology may only be performed, including in an emergency, with the participation of at least: 1° One doctor with proven training in the pract…
The authorisation holder is subject to the obligation of quality assurance defined in I of Article L. 1333-19 and in Article R. 1333-70.
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