Essentials of European Medical Device 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

Macleans, Sensodyne and rings are trademarks of GSK

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Module 2

• Who’s who? Key Stakeholders

– Regulatory Agencies – Competent Authorities

– Notified Bodies

– European committees and organizations

– Companies

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