A revision to the MDR has been published by the EU in which they intended to streamline the UDI requirements for certain products, starting with contact lenses. This new revision sees an easing of the UDI requirements for contact lenses and hence a reduction in the associated administrative burdens by allowing for manufacturers to assign a Master UDI-DI to such devices instead of individual UDI-DI’s.
The amendment to the regulation allows for the manufacturers of standard and made to order contact lenses with the same design parameters to be grouped together under one Master UDI-DI.
The amendment in the regulation can be accessed using the following link
