(fra kommisjonsforordningen)

(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 required to assign to the device and to all higher levels of packaging of the device, a UDI. The UDI comprises of 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 assigned to a specific model of device and manufacturer. Spectacle frames, spectacle lenses and ready-to-wear reading spectacles, also called ready-made reading spectacles or ready readers, are available in many variants due to the high number of design (clinical and non-clinical) parameters and construction variants that characterise them. As a result an UDI-DI is assigned to each such variant. This individualisation at UDI-DI level results in a proliferation of UDI-DIs to be assigned to similar spectacle frames, spectacle lenses and ready-to-wear reading spectacles and a disproportionate number of UDI-DI data entries in Eudamed relative to the safety risk associated with these products. 

(3) Developments at international level and discussions with issuing entities, industry and other relevant stakeholders, and Union competent authorities for medical devices, together with the technical progress, suggest that certain highly individualised devices such as spectacle frames, spectacle lenses and ready-to-wear reading spectacles that have the same design (clinical and non-clinical) 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 spectacle frames, spectacle lenses and ready-to-wear reading spectacles, a solution is therefore needed for UDI-DI assignment to these products. 

(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,