Ophthalmic manufacturers get UDI guidance from MDCG
In a new position paper, the EU’s Medical Device Coordination Group (MDCG) has provided detailed information about device identifiers for eyeglass and lens manufacturers.The position paper is meant to clarify how manufacturers of spectacle lenses and “ready readers,” or non-prescription reading glasses, should address unique device identification (UDI) requirements under the newly applied Medical Devices Regulation (MDR).
Articles 10(7) and 27(3) of the MDR obligate device manufacturers to comply with UDI requirements and mandate that a device and its higher levels of packaging, if applicable, be assigned a UDI.
The position paper, in two annexes, gives manufacturers of spectacle lenses and ready readers details of UDI assignment for their products.
“Bearing in mind the requirement for appropriate and uniform identification, taking into account the nature of Spectacle lenses and Ready readers and the interest of proportional data entries in EUDAMED, data elements applicable to these products and their potential triggers have been defined accordingly,” according to the position paper.
The first annex lays out UDI-DI level assignments for spectacle lenses, based on such device attributes as the commercial index value; options such as whether the lens is photochromic, polarized or clear; lens design variation such as whether the lens is single-, bi-, multi-focal or is of variable power; and whether the lens is mineral (glass) or organic (plastic/polymer). For the UDI DI level assignments, the additional category of the commercial name of the lens is added.
Ready readers are addressed in the second annex. Here, the BASIC UDI-DI level assignment is determined by frame construction, frame material and lens material attributes. The UDI-DI level assignment is determined by attributes related to the product’s commercial name, color, lens width, nose width, power and lens material.
The unit of device production, identified via alphanumeric code, is required for both types of lenses. For both European and worldwide ophthalmic manufacturers, this identifier is not related to the prescription parameter of the customer for the spectacle lenses or ready readers.
MDCG