Article R5211-23
In order to comply with the essential requirements relating to design and manufacture, active implantable medical devices must be designed, manufactured and packaged in such a way as to meet the follo…
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Showing 931–940 of 3089 articles for “Art. 23 nov. 2011”
In order to comply with the essential requirements relating to design and manufacture, active implantable medical devices must be designed, manufactured and packaged in such a way as to meet the follo…
As part of the procedure applicable to in vitro diagnostic medical devices undergoing an assessment of their performance, the manufacturer must draw up a declaration containing the data enabling the d…
Manufacturers of medical devices and the companies and organisations operating these devices shall, at the reasoned request of the Director of the Agence nationale de sécurité du médicament et des pro…
Failure to comply with the provisions of the third paragraph of Article L. 6144-1 and the fourth paragraph of Article L. 6161-2 may be recorded by the Director General of the Regional Health Agency, p…
The authorisation holder shall carry out the assessment referred to in Article L. 6122-5, in accordance with the conditions laid down in this section.The purpose of this evaluation is to check that th…
The establishment keeps a continuous chronological register in the emergency department, showing the identity of patients admitted, the day, time and method of their arrival, their referral or hospita…
Employees are bound by professional secrecy under the conditions laid down by law. Inspection officers and prevention engineers are prohibited from disclosing any manufacturing secrets or operating pr…
This section applies to the staff of companies providing catering on trains and companies operating sleeping accommodation on trains.
The health establishment authorised to carry out the activity mentioned in 3° of Article R. 6123-1 :1° Sets up the premises and equipment to allow access to vulnerable persons, in particular disabled…
…esthesia and intensive care in conjunction with the medical staff mentioned in I of article D. 6124-235 with the aim of ensuring the safety of the care provided. The doctors specialising in anaesthesi…
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