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Showing 1341113420 of 39711 articles for Art. al. 3

French Public Health CodeIn force
Section 1: General provisions

Article R5213-3

The information contained in each advertisement must be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the m…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 1: Maintenance and quality control obligations

Article R5212-32

…cond quality control carried out on the device in accordance with the provisions of Article R. 5212-30.If, after this second inspection, the expected performance of the device is still not achieved, t…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 8: Declaration.

Article R5221-36

The content and methods of presentation of the declaration are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order o…

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

Article R5221-30-1

The bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…

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 R5221-13

The presentation at scientific or technical meetings, exhibitions and demonstrations of in vitro diagnostic medical devices which do not comply with the provisions of this Title is authorised provided…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 1: Maintenance and quality control obligations

Article R5212-33

…e quality control has led to the reporting of a risk of incident as provided for in Article R. 5212-31, the operator shall notify the Director General of the Agence nationale de sécurité du médicament…

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

Article R5211-23-1

…August 2012 on specific requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC for active implantable medical devices and medical devices manufactured utilis…

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

Article R5146-1-3

…cting pharmacists and veterinarians mentioned in article R. 206-1 and in 2° of the I of article R. 231-3-7 of the rural and maritime fishing code working as inspectors for the agency when they have al…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Subsection 2: Applicable procedures.

Article R5211-34

…ation of conformity, associated with the EC declaration of conformity, product quality assurance, ; 3° For Class II b medical devices, either : a) the EC declaration of conformity, full quality assura…

AI translation · Updated 1 Nov 2023Open Article
French Public Health CodeIn force
Section 1: Scope of application.

Article R5211-3

…Products which, because of their principal mode of action, are considered to be medicinal products; 3° Cosmetic products;4° Human blood, blood products, blood cells of human origin or devices containi…

AI translation · Updated 1 Nov 2023Open Article
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Mariela Petrova

Mariela Petrova

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