Essentials of European Medical Device Regulatory Affairs - June 2020

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.

TheOrganisation for Professionals in Regulatory Affairs

1. Medical device or not a medical device?

2. A potential question for the regulatory department

TheOrganisation for Professionals in Regulatory Affairs

Three toothpastes:

Sensodyne rapid relief •Clinically proven to relieve the pain of sensitive teeth •Mineral like seal over the dentine and within microscopic channels

Sensodyne total care •Clinically proven relief from the pain of sensitive teeth •Potassium nitrate relieves the pain of sensitive teeth by directly calming the nerve endings inside teeth

Macleans •Deep down protection against plaque and decay •Clinically proven for healthy gums •Antibacterial action for protection against bad breath

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Macleans,Sensodyne and ringsare trademarksofGSK

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