When would a notified body be involved in relation to contact lenses under MDR 2017/745?

Under MDR 2017/745, contact lenses can be classified as Class IIa, Class IIb, or Class III medical devices depending on their intended use and duration of contact. The classification dictates the required conformity assessment procedures. Class IIa, IIb and III devices require notified body involvement for conformity assessment.

Contact lenses may also be regulated under Annex XVI of MDR 2017/745 where they do not have an intended medical purpose. These products also require notified body involvement for conformity assessment.