Part B: Core data elements to be provided to the udi database together with the udi-di in accordance with articles 25 and 26

The manufacturer shall provide to the UDI database the UDI-DI and 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 24(6) 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’ UDI-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 28(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 23,

9.risk class of the device,

10.if applicable, name or trade name,

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

12.additional product description (optional),

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

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

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

16.if applicable, the maximum number of reuses,

17.device labelled sterile (y/n),

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

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

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

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