The regulation introduced the concept of substance-based medical devices and defined their classification according to the new rule 21 (annex VIII).
What does rule 21 imply
medical devices composed of substances or combinations of substances and that are intended to be introduced into the human body through a body orifice or applied to the skin and that are absorbed by or locally dispersed into the human body are classified as:
- Class III if said medical devices or their metabolic derivatives are absorbed systemically by the human body in order to achieve their designed effect
- Class III if they achieve their designed effect in the stomach or in the lower gastrointestinal tract, and if they or their metabolic products are absorbed systemically by the human body
- Class IIa if they are applied on the skin, or inside the nasal or oral cavities down to the pharynx, and achieve their designed effect on said cavities
- Class IIb in all other cases