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Native speakers reviewed regulations, case law and garment claims in each language.
Case Study · Regulatory Assessment
Clarifying when sportswear becomes a medical device.
A global athletic apparel company wanted to know where its compression garments end and medical devices begin, country by country. We studied the rules, tested them on the ground and flagged the markets that need care.
The Client
The client is a global athletic apparel company looking at medical compression as a new market. It needed to understand the rules for compression claims on garments around the globe.
The Challenge
Draw the line.
Protect the claims.
Prescouter was asked to define the boundary between non-medical and medical compression garments, what would make a garment a medical device, and which performance marketing language is allowed.
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Classification
Garment or device
What turns a compression garment into a medical device.
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Claims
Marketing language
Which performance claims are allowed in each country.
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Markets
Country by country
Where the client’s plans could meet conflicts.
Our Approach
Mapping the rules through research, outreach, and experts.
Pharmacy outreach
Pharmaciescontacted in each country
Test on the ground
We asked which compression levels could not be sold over the counter.
Expert input
Expertssubject matter experts
Check the findings
Experts tested the conclusions drawn from the research.
The Outcome
A clear view of where claims could cause trouble.
Prescouter delivered a high-level overview of each country studied, pointing out areas that could conflict with the client’s planned compression and performance marketing claims. With a complex regulatory space distilled, the client could focus its product development, marketing and legal teams on the countries that need attention.
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Product
Stay on the right side
What keeps a garment out of the medical device class.
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Marketing
Safe claims
Language that fits the rules in each market.
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Legal
Focus areas
Countries that need a closer look.
One word on a label can turn a garment into a medical device. Knowing the rules in each country keeps a launch on track.
Let’s Talk
Are your product claims ready for every market?
Review the rules country by country and see where your plans may meet conflicts. Wherever you’re starting from, we’ll help you get there.
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