Out of Compass v1 scope
Annex XVI — no medical purpose
Annex XVI groups products without an intended medical purpose (e.g. cosmetic contact lenses, dermal fillers) that the MDR brings under regulation via Implementing Regulation 2022/2346. The classification framework differs from Annex VIII.
Recommended next step
Map your device to the relevant Annex XVI group and consult IR 2022/2346 for the specific common specifications. Compass v2 will cover this scope.
Compass covers all MDR risk classes (I–III) under Annex II/III. These categories fall under a different regulatory regime, so we route you to the right resources instead of guessing.