Article | REF: J4000 V1

Borderline Products - Regulatory Challenges and Impact on Design and Innovation

Author: Mathieu BOUARFA

Publication date: June 10, 2025 | Lire en français

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    2. (Re)classification criteria: example of a mouthwash

    Product classification, right from the earliest stages of design, is a critical factor in guaranteeing optimal, compliant marketing.

    Three cases are possible:

    • use regulations to innovate or simply to comply with product development and marketing guidelines;

    • not knowing how to choose the product's regulatory status for various reasons (lack of knowledge, legal uncertainty or lack of regulations specific to the future product);

    • undergo reclassification, notably by national authorities.

    The criteria for determining or reclassifying a product between different regulatory categories are complex, and vary according to a number of factors. This section details these criteria and explores their implications for product design...

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