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MDR Annex I chapter 23.2 (q) - Information required on the label

Wolf.K

Involved In Discussions
#1
Hi,


I try to understand the implication of MDR Annex I Chapter 23.2 (q):


The label shall bear all of the following particulars:
(q) an indication that the device is a medical device.


I think there is no symbol for medical devices, right? So, do I need to write "This product is a Medical Device" on the label? In all official languages of the EU???


? W.
 
Last edited:
#2
Good question! Translation being a continual challenge in the EU, we'd sooner not add additional text that is subject to translation.

I'd hope that, in practice, the totality of other items on the label (CE mark & Cert.No., NB number, Authorized Representative,...) would suffice to indicate the product is a medical device. Otherwise, without some universal symbol, it'd seem unecessarily onerous to require text as as benign as "This is a medical device", that would need to be translated into all EU languages.
 

ryannh

Starting to get Involved
#3
I was just discussing this earlier today. I was under the impression that a symbol was going to be published similar to the IVD symbol that is in EN ISO 15223-1. Review of a BSI white paper didn't provide any clarity.

Hopefully someone closer to the action can provide some additional information. Thx
 

Wolf.K

Involved In Discussions
#4
A friend of mine knows someone how knows a lot (of people)... So I got the info, that a symbol similar to the [IVD], that is, [MD] can already be part of the label, as long as it is defined in the list with the symbols. EU regulation allows that you can create your own symbols, as long as you define them. But I was not able to find information on the font type, letter size and how thick the black rectangle around the MD letters has to be. ISO 3461 or ISO IEC Guide 74 do not proide this information?
 

Wolf.K

Involved In Discussions
#5
I have heard, that in the new ISO 15223-1 DIS there is a "MD" symbol included. Can anyone confirm this, and does anyone know when the updated standard will be published? Updating every five years might mean somewhere in 2021?
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#6
Yes, the CD/DIS does have a medical device symbol, the comments will be discussed in October in London. Publication date is expected for November next year.
 
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