Symbol MD in the label of Medical Devices Class I (no sterile)

All class I medical devices according to the MDR, from today, have to be in compliance completely with the MDR Technical requirements (Annex 2 _ Technical documentation). One of those requirements is to have an MD symbol on the label. For details on what needs to be on the label, please see section 23 of Annex 1 – General safety and performance requirements.

For more information, please see:

• EU MDR Annex 1 – General safety and performance requirements https://advisera.com/13485academy/mdr/general-requirements/
• EU MDR Annex 2 – Technical  documentation https://advisera.com/13485academy/mdr/technical-documentation/

Is the MD Symbol on the label mandatory for all Classes of Medical Device?  

Yes it is, it is stated in the Annex I General safety and performance requirements, section 23.2 The label shall bear all of the following particulars: q) an indication that the device is a medical device

For more information, see:

• EU MDR Annex 1 – General safety and performance requirements https://advisera.com/13485academy/mdr/general-requirements/

Can MD symbol be used on the label of a medical device that is in compliance with MDD? Or it is restricted for devices in compliance with MDR?

It is not forbidden to put it on the MDD compliance device, but it means that you need to implement ISO 15223-1:2021 into your system, so all symbols that are required in that standard and applicable for your device should be implemented. Also, it means that you need to change your essential requirement checklist with this new standard.