PART B

Core data elements to be provided to the UDI database together with the UDI-DI in accordance with articles 28 and 29

The manufacturer shall provide to the UDI database the UDI-DI and all of the following information relating to the manufacturer and the device:

1. quantity per package configuration,

2. the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,

3. the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number),

4. if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use, a ‘unit of use’ DI shall be assigned so as to associate the use of a device with a patient),

5. name and address of the manufacturer (as indicated on the label),

6. the SRN issued in accordance with Article 31(2),

7. if applicable, name and address of the authorised representative (as indicated on the label),

8. the medical device nomenclature code as provided for in Article 26,

9. risk class of the device,

10. if applicable, name or trade name,

11. if applicable, device model, reference, or catalogue number,

12. if applicable, clinical size (including volume, length, gauge, diameter),

13. additional product description (optional),

14. if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),

15. if applicable, additional trade names of the device,

16. labelled as a single-use device (y/n),

17. if applicable, the maximum number of reuses,

18. device labelled sterile (y/n),

19. need for sterilisation before use (y/n),

20. containing latex (y/n),

21. where applicable, information labelled in accordance with Section 10.4.5 of Annex I,

22. URL for additional information, such as electronic instructions for use (optional),

23. if applicable, critical warnings or contra-indications,

24. status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).