Italy Ministry of Health clarifies ophthalmic lens regulations

The Italian Ministry of Health has issued a clarification regarding the classification of ophthalmic lenses. The Ministry stated that the standard adaptation and mounting of corrective ophthalmic lenses does not constitute the manufacture of a custom medical device.

Because these lenses are mass-produced and CE-marked medical devices, the subsequent adjustment to a user's specific characteristics does not change their status. Consequently, opticians performing routine mounting and adjustment are not classified as manufacturers and are not required to register in the database for manufacturers of custom medical devices or obtain an ITCA number for these specific activities.