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 v1 covers Class I and IIa devices under MDR Annex II/III only. We may expand coverage in v2.