PhaRegistrum · Originally published on 15/01/2026
Are microabrasion dental stain removers medical devices or cosmetics?
Version 4 of the MDCG Manual on Borderline and Classification for Medical Devices clarifies that removing dental stains for aesthetic purposes, even by microabrasion, is not a medical purpose.
Medical device classification requires robust scientific evidence of use to prevent, treat or alleviate disease. Without it, products should be classified as cosmetics.
Correct qualification is essential for MDR and IVDR compliance and avoiding incorrect frameworks.
PhaRegistrum helps manufacturers and distributors interpret and apply these requirements.
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