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