Article D6211-8
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 corr…
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Showing 6351–6360 of 37448 articles for “Art. D 442-3”
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 corr…
A medical biology laboratory may decide to terminate its functions as a reference medical biology laboratory, subject to nine months' notice. Failure to comply with this time limit exposes the medical…
An order of the Minister for Health shall determine the nature of the samples to be kept after the analytical phase has been completed, as well as the duration and conditions of storage of these sampl…
The biologist-in-charge of the laboratory where the replacement is to take place must notify the director of the regional health agency at least fifteen days in advance, except in cases of force majeu…
External quality assessment bodies use a coding system to identify the techniques used in the analytical phase of each examination. Where quality control of a medical biology examination is carried ou…
The head of the medical biology laboratory holding the authorisation is required to declare without delay to the Minister responsible for health any change relating to the legal rules and technical op…
The competent authorities of the State in which the laboratory has its registered office are informed of the decision of the Minister for Health.
Renewal applications follow the same procedure as initial applications.
I.-Medical biology laboratories shall submit each analytical system they use to an external quality assessment. II.-Each external quality assessment body for medical biology examinations mentioned in…
The authorisation is issued for a period of five years. It specifies the medical biology tests or families of medical biology tests that the laboratory is authorised to perform at the request of a med…
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