Article R5221-1
The provisions of this Title apply to in vitro diagnostic medical devices as defined in Article L. 5221-1.
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Showing 12561–12570 of 15302 articles for “Art. 12 al. 2”
The provisions of this Title apply to in vitro diagnostic medical devices as defined in Article L. 5221-1.
…of devices and send it the batch release certificate for the substance referred to in Article R. 5212-24 used in this device, drawn up by the Agence nationale de sécurité du médicament et des produit…
…within the scope defined in paragraphs 2 and 4 of Article 1 of Commission Regulation (EU) No 722/2012 of 8 August 2012 on specific requirements as regards the requirements laid down in Council Direct…
…they have already sworn an oath respectively as inspectors of the pharmacy mentioned in article L. 5127-1 or under the conditions of article R. 205-1 of the rural and maritime fishing code.
…onstrated; 11° Single-use device means a device intended to be used only once for a single patient; 12° Subcategory of devices means a group of devices having common fields of use or a common technolo…
…e meaning of this Title and as personal protective equipment within the meaning of Articles R. 4311-12 to R. 4311-14 of the Labour Code also complies with the essential requirements mentioned in Artic…
…ess, in accordance with the procedures specified in Article 5(2) to (7) of Regulation (EU) No 722/2012 of 8 August 2012 on specific requirements as regards the requirements laid down in Council Direct…
For the purposes of this Title, the following definitions shall apply1° Operator of a medical device: any natural or legal person who assumes legal responsibility for the activity requiring the use of…
…shall examine at least the aspects provided for in point 2.2 of Annex I to Regulation (EU) No 722/2012 of 8 August 2012 on specific requirements as regards the requirements laid down in Council Direct…
Articles R. 523-12 to R. 523-21 of the Environmental Code apply to nanoparticulate substances used in the composition of health products intended for humans, cosmetic products mentioned in article L.…
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