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Showing 1301–1310 of 4485 articles for “Art. CA Paris 18 février 1994”
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.
…s 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; 2° The device comes f…
The certificate is accompanied by a file containing the following information: 1° The results of the quality controls mentioned in articles L. 6221-9 and L. 6221-10, carried out during the previous fi…
…The authorisation holder provides access, on site or by agreement, to -a workshop for fitting technical aids and prostheses ; -a movement analysis laboratory.
…s, 24 hours a day, every day of the year: 1° For Rhythmology modality A, the presence on site or on call of a doctor specialising in cardiovascular medicine; 2° For Rhythmology modality B, C or D ment…
Authorisation for interventional activity using medical imaging in cardiology may only be granted if the equipment is connected to a system for archiving and sharing images in order to improve the qua…
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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