ISO 15223 Question

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#1
"These symbols can be used on the medical device itself, on its packaging or in the accompanying information"

The use of the word "can" and the word "or" this has created an interpretation question for us. Does this statement from the standard mean we must use these symbols in one of the three locations referenced? All of them? None of them?

Also,
Does the Model Number Symbol from the ISO 15223 standard have to be used every place the model number is printed on the device, packaging, and the instructions for use?

Where should the Medical Device Symbol from the ISO 15223 standard be placed? Is just on the outer packaging enough?

Does the Country of Manufacture Symbol from the ISO 15223 standard have to be used every place the country of manufacture is printed on the device, packaging, and the instructions for use?
 
Last edited:
Elsmar Forum Sponsor
#2
The use of the word "can" and the word "or" this has created an interpretation question for us. Does this statement from the standard mean we must use these symbols in one of the three locations referenced? All of them? None of them?
I believe they make this vague because of the number of different devices and regulatory requirements out there. Also, for example, it might make sent to have one symbol in one location but not another.

Check out the regulatory requirements for labeling first, then fill in the gaps with the standard.
 

Billy Milly

Involved In Discussions
#3
You need to label all the relevant info (ID, manufacturer, REF, precautions...) according to relevant legislation and your risk analysis. You can use the text (in all relevant languages) or symbols from 15223.
That's the reason the standard says "can". Labelling is determined by regulations, you can use "words" (which you have to translate) or symbols (which, if used, shall be 15223-compliant).

MDR requires the device itself (or the sterile barrier/primary packaging, if direct labelling is not possible) to be labelled as "medical device". Again, words or symbol, your choice.

HTH
 
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