Article R5221-22
For the purposes of placing on the market in vitro diagnostic medical devices other than those subject to a performance evaluation, manufacturers shall follow the following procedures: 1° For in vitro…
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Showing 5531–5540 of 56672 articles for “Art. L. 143-2”
For the purposes of placing on the market in vitro diagnostic medical devices other than those subject to a performance evaluation, manufacturers shall follow the following procedures: 1° For in vitro…
The in vitro diagnostic medical devices referred to in Article L. 5221-5 may be exempted from conformity assessment procedures only if the procedure corresponding to the category of device does not in…
The manufacturer may instruct his authorised representative to initiate the procedures mentioned in 1°, 2°, 4° and 5° of article R. 5221-19.
The employer referred to in the third paragraph of article R. 8291-1 shall make a declaration to the union of funds referred to in article R. 8291-2 for each employee seconded to France, prior to the…
…ability for quality control of the results of the medical biology examinations mentioned in Article L. 6221-9. This order may define the minimum number of annual participations. It is issued and amend…
…me of controls carried out by the Agency, in the light of the annual reports referred to in Article L. 6221-9 which are sent to it by the external quality assessment bodies. This programme is communic…
…nt. II.-Each external quality assessment body for medical biology examinations mentioned in Article L. 6221-9 carries out an inter-laboratory comparison of the results obtained and a comparison of res…
I.-The external quality assessment bodies referred to in article L. 6221-9 must meet the following criteria: 1° Competence, in terms of qualifications and experience, to organise quality control campa…
The agenda is set by the Chairman. In particular, the agenda must include matters falling within the remit of the committee, the examination of which has been requested by at least half of the full em…
Committee meetings are convened by the Chairman, either on his own initiative or at the written request of at least half of the permanent employee representatives. In the latter case, the committee mu…
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