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Showing 1256112570 of 15302 articles for Art. 12 al. 2

French Public Health CodeIn force
Section 1: Scope of application.

Article R5221-1

The provisions of this Title apply to in vitro diagnostic medical devices as defined in Article L. 5221-1.

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 5: EC declaration of conformity, full quality assurance system.

Article R5211-40

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 5: Essential health and safety requirements.

Article R5211-23-1

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Single section

Article R5146-1-3

…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.

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 2: Definitions

Article R5211-4

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 4: Conditions for placing on the market and putting into service.

Article R5211-17

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 6: EC type-examination.

Article R5211-41-1

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 2: Definitions

Article R5211-5

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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 7: Authorised bodies

Article R5211-62

…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…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Title VI: Health products containing nanoparticulate substances

Article R5161-1

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.…

AI translation · Updated 1 Nov 2023Open Article
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