Unfortunately it looks to be getting tougher. My understanding...

Unfortunately it looks to be getting tougher. My understanding isthat under EU MDR Rule 21 Suda’s products will fall into class lll with theassociated consequences.

MDR Rule 21

Devices that are composed of substances or of combinations ofsubstances that are intended to be introduced into the human body via a bodyorifice or applied to the skin and that are absorbed by or locally dispersed inthe human body are classified as:

•class III if they, or their products of metabolism, aresystemically absorbed by the human body in order to achieve the intendedpurpose;

•class III if they achieve their intended purpose in the stomachor lower gastrointestinal tract and they, or their products of metabolism, aresystemically absorbed by the human body;

•class IIa if they are applied to the skin or if they are appliedin the nasal or oral cavity as far as the pharynx, and achieve their intendedpurpose on those cavities; and

classIIb in all other cases.

https://arcoro.de/en/nasal-sprays-oral-sprays-lozenges-are-you-familiar-with-the-regulatory-amendments-due-to-the-mdr/