EU and US differ over regulation of plano contact lenses:
This article was originally published in Clinica
Executive Summary
Plano (non-prescription) decorative contact lenses are not regulated as medical devices in the EU because the Medical Devices Directive (MDD) explicitly covers devices "intended to be mainly for a medical purpose". That was the response by the European Commission to a written question raised by UK MEP Glenis Willmott, who wanted to know why such lenses were not classified as medical devices in the EU, when they are in the US. "Both corrective and non-corrective lenses have the same potential health risks and effects on the eye if improperly manufactured or used without the consultation and supervision of an eye practitioner," she observed. The Commission emphasises that products intended to have a merely aesthetic purpose are not medical devices and that this is made clear in the EU guidance document, Meddev 2.1. The Commission does not offer in its response any clarification as to how plano lenses might be regulated.