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. 

Hi, I am not sure that your a statement that it is a requirement that medical devices have the symbol MD is correct. EU2017/745 Annex 1, 23.2 states the devices shall be identified on the label. It does not say anything about the use of a MD symbol. The MD symbol is mentioned as an example fop the way Implant cards for implantable medical devices - EU2017/745 can be developed, Article 18. However it is not actually a mandatory. Can you please expand on where you got this idea from?

MD symbol is a part of the standard ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements. Since ISO 15223-1:2021 is from 04th January 2022 and published in the Official Journal of the European Commission it is mandatory.

For more information regarding the harmonized standards, see the following link:

• Commission Implementing Decision (EU) https://eur-lex.europa.eu/eli/dec_impl/2022/6/oj
• ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements - https://www.iso.org/standard/77326.html

   

Yes I understand that if you choose to use symbology you have a standard set of symbols that you may use and these are listed in ISO 15223. However, the actual requirement is from EU 2017/745 Annex I, Chapter III, 23.1 "General requirements regarding the information supplied by the manufacturer", indent (q) "an indication that the device is a medical device".

Such an indication can be the words "Medical Device". If you choose to use symbology then do it according to ISO 15223 but it is not a requirement to use a symbol... It is a requirement to indicate that it is a medical device and these words, if there is room on the label, are just as acceptable... Are you sure of your statement that it is a requirement to put "MD" in a label?  

If you put the words "Medical device", it is acceptable. 

Is the MD symbol required for accessories?
We have some hardware equipment that can be used with our medical devices. The equipment is classified as an accesory, although it is not a device in its own right. Does the accessory require the MD symbol?

For the accessories, it is not required to have an MD symbol.

which countries require only MD symbol but not CE

The "MD" symbol, as defined in ISO 15223-1:2021, is used to indicate that a product is a medical device. Its usage is particularly relevant in the context of the EU Medical Device Regulation (MDR) 2017/745. While the "MD" symbol is recognized within the EU and associated countries, its acceptance and requirement outside this region vary.
The CE marking is mandatory for medical devices placed on the market within the European Economic Area (EEA), which includes all EU member states, as well as Norway, Iceland, and Liechtenstein. Additionally, countries like Turkey and Switzerland have agreements that align their regulations with the EU, making the CE mark a requirement for medical devices in these markets.
In contrast, many countries outside the EEA do not require the CE mark for medical devices. Instead, they have their own regulatory frameworks and labeling requirements. For instance, the United States requires medical devices to comply with FDA regulations, while Canada mandates adherence to Health Canada's Medical Devices Regulations. In these countries, the "MD" symbol is not a recognized or required labeling element.
Therefore, the "MD" symbol is primarily required in the EU and countries that have adopted the EU's medical device regulations. Countries outside this regulatory sphere do not mandate the "MD" symbol and have their specific labeling requirements.

Thank you, Kristina for the detailed response.