The Netherlands
The Keuringsraad has announced a change in how toothpastes carrying a CE mark are treated under self-care advertising rules.
The Keuringsraad reviews consumer advertising for, among other things, self‑care medical devices against the CPMH (Code voor Publieksreclame voor Medische Hulpmiddelen or the code for consumer advertising for medical devices). However, the CPMH does not apply to all medical devices. It covers only those medical devices presented in a pharmaceutical form, meaning substances or materials with a physical mode of action that are offered in a pharmaceutical dosage form.
Until now, toothpastes with a CE mark were classified as medical devices in a pharmaceutical form and were therefore subject to the CPMH. In practice, however, most toothpastes are cosmetic products. This raised the question of whether CE‑marked toothpastes truly qualify as being presented in a pharmaceutical form.
It has now been decided that CE‑marked toothpastes will no longer be considered medical devices in a pharmaceutical form and will therefore no longer be assessed under the CPMH. The key distinction from regular toothpastes remains the medical claims that may legally be made; otherwise, the same advertising rules apply as for all other toothpastes.
Should a toothpaste be introduced in the future as a medical device containing a pharmacologically active substance that supports the physical effect and is therefore classified as a Class III device, it may again be considered as a medical device in a pharmaceutical form.