Essentials of European Medical Device Regulatory Affairs

Borderline with other Directives

• Skin peeling products (device or cosmetic) – Depends if a medical claim (appearance vs scar removal) – Depth (top layer of skin or deeper action) – Frequency of application • Insect repellent (device or biocide) • Manufacturer wanted a medical claim of prevention of injuries from insects • No - primary action is to repel insects (and not humans) and so not a medicinal claim. It is a biocide.

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Exercise 1

• Medical device or not a medical device?

• A potential question for the regulatory department

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