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Article D6211-8 of the French Public Health Code

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…

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Article D6211-9 of the French Public Health Code

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…

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Article D6211-10 of the French Public Health Code

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,…

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Article D6211-11 of the French Public Health Code

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.

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Article R6211-12 of the French Public Health Code

The derogation provided for, on public health grounds, in Article L. 6211-16, under which the taking of a biological sample is carried out in one of the health territories in which the medical biology laboratory is located, applies to the following cases: 1° (Repealed) ; 2° To the taking of a biological sample for a periodic health examination mentioned in articles L. 321-3 and R. 321-5 of the Social Security…

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Article D6211-13 of the French Public Health Code

For the application of Articles L. 6211-19, L. 6222-2, L. 6222-3 and L. 6223-4, the total number of medical biology examinations is obtained, for each laboratory, by adding together the number of unit examinations for which the result derives from an analytical phase, whether or not these unit examinations are subject to reimbursement. For examinations listed in the nomenclature of medical biology procedures drawn up in application of articles L….

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Article D6211-14 of the French Public Health Code

Before 31 March each year, each medical biology laboratory shall declare electronically to the regional health agency within whose jurisdiction it is established, the total number of medical biology examinations, as defined in Article D. 6211-13, that it has performed during the previous calendar year. This declaration distinguishes : 1° The number of tests performed on samples that it has taken or that were taken under its responsibility and for…

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Article D6211-15 of the French Public Health Code

For the application of articles L. 6211-19, L. 6222-2, L. 6222-3 and L. 6223-4, the percentages are calculated on the basis of the previous calendar year and, in the absence of a full calendar year of activity of the laboratory, on the basis of the completed days of activity.

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Article D6211-16 of the French Public Health Code

For the application of article L. 6222-2, the supply of medical biology examinations for a zone defined in b of 2° of article L. 1434-9 corresponds to the total number of examinations mentioned in 1° and 2° of article D. 6211-14, the sampling of which was carried out in this same health territory. The needs of the population in the zone mentioned in the same article are those set out…

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Article D6211-16-1 of the French Public Health Code

The examinations mentioned in Article D. 6211-16, the analysis of which was carried out in medical biology laboratories under the authority of the Minister for Defence and not included in the list provided for in II of Article L. 6147-7, are not taken into account in the total number of examinations.

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