MDR - annex VI - PArt B - article 2
Original text
Expert opinion
2. the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs
Core data which are to be provided to the EUDAMED before marketing a product, include the UDI-DI.
In addition, the UDI-DI shall be provided beforehand in cases of a conformity assessement by authorities.
The UDI-DI applies to medical devices, procedure packs and kits.
Exempt from this are custom-made devices.
