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.
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
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:
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?
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?