(1)

Regulation (EU) 2017/745 provides for a Unique Device Identification (UDI) system for the identification and traceability of devices. Before placing a device, other than a custom-made device, on the market, the manufacturer is to assign to the device and to all higher levels of packaging of the device a UDI. The UDI comprises a device identifier (UDI-DI) and a production identifier (UDI-PI). The UDI-DI is one of the core elements which a manufacturer needs to provide to the UDI database in the European database on medical devices (Eudamed).

(2)

A UDI-DI is to be assigned to a specific model of device and manufacturer. Contact lenses are available in many variants due to the high number of clinical parameters that characterise them. In accordance with Regulation (EU) 2017/745, an UDI-DI is to be assigned to each of such variants of contact lenses. This individualisation at UDI-DI level, that results in a proliferation of UDI-DIs to be assigned to similar contact lenses, overwhelms Eudamed and is disproportionate compared to the safety risk associated with contact lenses.

(3)

Taking into account progress at international level and collaboration with issuing entities, concerned industry stakeholders and Union competent authorities for medical devices, the technical development in this field is such that contact lenses that have the same clinical and design parameter combinations are more appropriately grouped under the same UDI-DI (Master UDI-DI). In order to avoid assignment of different device identifiers to very similar contact lenses, a solution is therefore needed for UDI-DI assignment to contact lenses.

(4)

Regulation (EU) 2017/745 should therefore be amended accordingly.

(5)

In order to comply with the amendments made by this Regulation economic operators must implement changes in their internal systems and adapt technologies for printing and scanning UDI carriers. The application of this Regulation should therefore be deferred,