According to Article 29 (2) of MDR (EU) 2017/745, before placing a system or procedural set on the market under Article 22(1) or 22(3) – provided it is not a custom-made device – the manufacturer is obliged to:
- Assign a Basic UDI-DI code, following the rules set by the authorised issuing body (e.g. GS1, HIBCC, ICCBBA);
- Register the Basic UDI-DI in the European database EUDAMED, together with the other essential device data.
