Bar codes under MDR

In MDR, Chapter III - Requirements regarding the information supplied with the device it is stated that all labels for medical devices must be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.

In ANNEX VI – Information to be submitted upon the registration of devices and economic operators, in Part C are guidelines on how to implement bar code in UDI number.

There are also several guidelines from the Medical device coordination group (MDCG) showed in the table:

MDCG 2018-1 v3                Guidance on basic UDI-DI and changes to UDI-DI

MDCG 2019-1                     MDCG guiding principles for issuing entities rules on basic UDI-DI

MDCG 2019-2                     Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and                                                1(10) of Regulation 745/2017
MDCG 2018-2                     Future EU medical device nomenclature - Description of requirements

Link to this table and all guidelines is: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

For more information, see the following article: 

EU MDR – Easy-to-understand basics https://advisera.com/13485academy/what-is-eu-mdr/