Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (1), in particular Article 27(10), point (b) thereof,
Whereas:
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)…
