Case studies of frontier products
Borderline Products - Regulatory Challenges and Impact on Design and Innovation
Article REF: J4000 V1
Case studies of frontier products
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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3. Case studies of frontier products

Frontier products reveal the challenges of regulatory classification due to their hybrid nature. These detailed case studies analyze concrete examples from various sectors, examining their specific characteristics: product type, substance type, area of application, expected and foreseeable use, presentation and claim. These analyses help us to understand how regulatory frameworks influence their positioning on the market.

3.1 Hydroalcoholic hand gels

At first glance, hydroalcoholic gels might seem to fall into the regulatory category of medical devices. The table at 12 enables us to analyze the criteria for a medical device and apply them to hydroalcoholic gels.

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