Borderline Products & Switches

Borderline products are products whose status is not well defined because of their presentation, their function, or even their mode of action.

A switch is a change of a product’s status, either following a requalification by the Competent Authorities, or following the decision of the operator. Therefore, a medical device can be re-qualified in to a medicinal product if there is a pharmacological, immunological, or metabolic primary mode of action and a cosmetic product or a food supplement can become a medical device as soon as the applicant proves the legitimacy of a medical indication and that the mode of action of the product is not that of a medicinal product.

WHITE-TILLET advises and assists you to:

  • Determine the status of your borderline product
  • When it being a switch product :
    • Develop the product development plan;
    • Prepare the technical file;
    • Follow the procedure and assists you with the authorities.

 

Contact

+33 1 60 08 43 85
+33 1 60 08 00 22

24 Rue Gambetta 77400 LAGNY-SUR-MARNE, France