Introduction:

Cosmetic companies frequently face regulatory challenges due to improper or exaggerated claims. The EDA Claim Guideline clarifies the boundary between cosmetic and therapeutic claims.Medical device claims are closely tied to intended use and performance characteristics. The EDA requires that all device claims reflect approved technical documentation.

Intended Use and Claims Alignment

The intended use defined in:

Technical File
Label
IFU

must match:

Website content
Promotional material
Distributor statements
Inconsistency may trigger regulatory action.
Performance Claims
Examples include:
Accuracy percentage
Sensitivity/specificity
Duration of use
Sterility assurance

All must be supported by:

Clinical evaluation
Validation reports
Risk management documentation

Comparative Claims

Statements like:

“Better than competitor X”
“Most advanced device”
require documented, objective comparison data.
Unsubstantiated superiority claims are considered misleading.

Compliance Strategy

Medical device companies should implement:

Internal claim approval SOP
Regulatory review before marketing release
Distributor training program
Periodic compliance audit

Conclusion:

Claims are part of regulatory compliance, not just marketing strategy. In the Egyptian market, alignment between technical documentation and external communication is mandatory.