NOSE CLEANER (Regulation (EU) 2017/745)

Class: Class IIa, Rule 5: Invasive device: All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to a Class IIa, Class IIb or Class III active device, are classified as class IIa

NOSE CLEANER Capsules

Class IIa, Rule 21: Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx1, and achieve their intended purpose on those cavities

Conformity Assessment: Annex II and Annex III AND Chapter I & III of Annex IX OR Annex II and Annex III AND Annex X + Annex XI Part A (Production Quality Assurance) OR Annex II and Annex III AND Annex X + Annex XI Part B (Product Verification)

• Annex II is Medical Device Technical File preparation
• Annex III is documented on post-market us