EU MDR Rules for Cosmetic Lenses

Your cosmetic contact lenses are regulated just like a heart valve under European law.

The Medical Device Regulation, or MDR, is actually super strict and covers

way more than just hospital gear. It classifies everything from simple bandages to high-risk implants.

If you are making these, you have to slap a Unique Device Identifier on the

label so it can be tracked everywhere. But here is a wild loophole. If the device is

custom-made for a specific person, you do not even need the CE mark. Basically,

use harmonized standards as your cheat code for approval because the EU is watching everything that

touches a patient.