CE Marking of Teeth Whitening Kit

CE Certification of Teeth Whitening Kit 

Teeth Whitner (Regulation (EU) 2017/745)

There are two possibilities of Class: Class I, Class IIa, Rule 5 as per Annex VIII

Rule 5:  All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as Class I if they are used in the oral cavity as far as the pharynx, in an ear canal up to the eardrum or in the nasal cavity for short term use.

Class IIa: All invasive devices with respect to body orifices, other than surgically invasive devices, which are not intended for connection to an active device or which are intended for connection to a class I active device are classified as Class IIa if they are used in the oral cavity as far as the pharynx, in an ear canal up to the eardrum or in the nasal cavity and are not liable to be absorbed by the mucous membrane, for long term use.

Conformity Assessment:

1.Annex II and Annex III AND Chapter I & III of Annex IX

 OR

2. Annex II and Annex III AND Annex X + Annex XI Part A (Production Quality Assurance)

OR

3. Annex II and Annex III AND Annex X + Annex XI Part B (Product Verification)

Annex II is technical file preparation

Annex III is documented on post-market surveillance

Article 22: Systems and procedure packs