Subsection 1: Consistency between the data of the medical device or in vitro diagnostic medical device and the result of the medical biology examination

For the purposes of Article L. 6211-12, the result of the measurement of a test requiring a medical device or an in vitro diagnostic medical device is said to be consistent with the result of the corresponding medical biology examination when the two results are identical or when the difference between the two values generates therapeutic adjustments which remain identical. The two results are expressed in the same unit of…

For in vitro diagnostic medical devices used on an outpatient basis, the frequency of verification of the consistency referred to in Article D. 6211-8 is determined by the recommendations referred to in 2° of Article L. 161-37 of the French Social Security Code or those resulting from scientific evidence, or by the prescriptions contained in the instruction leaflet for the in vitro diagnostic medical device concerned if the latter are…

When communicating the results of the medical biology examination to the patient as part of his self-monitoring, the medical biologist shall indicate to the patient whether the result of the test measurement and the result of the examination are consistent within the meaning of Article D. 6211-8. The medical biologist’s conclusions regarding the consistency check are transcribed in the medical biology examination report. When the medical biologist identifies an inconsistency,…

For medical devices and in vitro diagnostic medical devices other than those mentioned in article D. 6211-9, the inspection is carried out, where applicable, in accordance with the procedures set out in the instruction leaflet for the device concerned.