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Home | French Legislation Articles | French Public Health Code | Regulatory part | Part One: General health protection | Book II: Donation and use of human body parts and products | Title IV: Tissues, cells and products | Chapter V: Common provisions | Section 4: Conditions for entry into or exit from national territory of elements or products of the human body mentioned in Article R. 1245-1 intended for the manufacture of in vitro diagnostic medical devices | Subsection 1: Provisions relating to the import and export of elements or products of the human body mentioned in Article R. 1245-1 from or to countries outside the European Union and the European Economic Area and intended for the manufacture of in vitro diagnostic medical devices. | Article R1245-20 of the French Public Health Code

French Public Health Code
- Regulatory part
  - Part One: General health protection
    - Book II: Donation and use of human body parts and products
      - Title IV: Tissues, cells and products
        Chapter V: Common provisions
        Section 4: Conditions for entry into or exit from national territory of elements or products of the human body mentioned in Article R. 1245-1 intended for the manufacture of in vitro diagnostic medical devices
        Subsection 1: Provisions relating to the import and export of elements or products of the human body mentioned in Article R. 1245-1 from or to countries outside the European Union and the European Economic Area and intended for the manufacture of in vitro diagnostic medical devices.

Article R1245-20 of the French Public Health Code

Article R1245-20 of the French Public Health Code

November 5, 2023
3:52 pm

Manufacturers of in vitro diagnostic medical devices may import or export tissues, their derivatives and cells from the human body, whatever their level of processing, when these products are intended for the manufacture of in vitro diagnostic medical devices meeting the requirements to which they are subject for their marketing.

The manufacturers concerned must declare their import activity to the Director General of the Agence nationale de sécurité du médicament et des produits de santé before it takes place.

Original in French 🇫🇷

Article R1245-20

Les fabricants de dispositifs médicaux de diagnostic in vitro peuvent importer ou exporter des tissus, leurs dérivés et des cellules issus du corps humain, quel que soit leur niveau de transformation, lorsque ces produits sont destinés à la fabrication de dispositifs médicaux de diagnostic in vitro répondant aux exigences auxquelles ils sont soumis pour leur mise sur le marché.

Les fabricants concernés déclarent leur activité d’importation préalablement à sa réalisation au directeur général de l’Agence nationale de sécurité du médicament et des produits de santé.

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