Translation requirement labels

[EmiliaP]

Hi everyone,

Tried to find a previous thread for this question, but no luck. If you know there is one, please let me know

I am facing a difficult discussing with one of our suppliers (and legal manufacturer) concerning the label for a Class IIb device.

As I have understood, and whatever info I find, ALL text content in both IFU and label needs to be translated to languages required? Or have I missed out on anything?

The label contains of applicable symbols, but also some text describing compatibility, lengths such as “For use with XXX monitors, XXX and instrument licenced to use XXX sensors”, also “Applied part: BF or CF, depending on the host device”

I have tried to refer to several articles/paragraphs in MDR, guidance document ect an that this information shall be stated in the IFU. But we do not agree upon that the text should either be translated or symbols shall be used to demonstrate the indication/meaning.

Am I wrong?

 

[Mark Meer]

Think of it this way: Does the text convey information necessary to use the devices as intended, or convey safety information? If so, translation is appropriate, don't you think? (regardless of what regulations dictate)

In general, our design strategy has always been to use symbols wherever possible on labels, and put all descriptive text (including explanation of the symbols' meanings, and safety information) into the IFU. The goal being that we only need to translate IFU as the labels don't have translatable text. That said, it doesn't always workout as sometimes labels need/include some text. In such cases we translate labels as well.

 

[EmiliaP]

Think of it this way: Does the text convey information necessary to use the devices as intended, or convey safety information? If so, translation is appropriate, don't you think? (regardless of what regulations dictate)

In general, our design strategy has always been to use symbols wherever possible on labels, and put all descriptive text (including explanation of the symbols' meanings, and safety information) into the IFU. The goal being that we only need to translate IFU as the labels don't have translatable text. That said, it doesn't always workout as sometimes labels need/include some text. In such cases we translate labels as well.

Thanks Mark Meer, always helpful to hear how others are doing!

 

[karan]

Hi All

I have similar questions like EmiliaP,

In our Medical device, we provided just information in label "Mains Power" for the power on LED indication. We plan to introduce symbol for mains power instead of text.

1. Can anyone suggest the IEC/ISO symbol for "Mains Power" indication.
2. If there is no such a symbol exist; then is it call for any language translation, when placing devices into EU market.

Looking forward to hear the response from others.

 

[Mark Meer]

...1. Can anyone suggest the IEC/ISO symbol for "Mains Power" indication.
2. If there is no such a symbol exist; then is it call for any language translation, when placing devices into EU market. ...

At the PSU & connector (if it's a detacheable cord), there are definitely symbols for specifying input power specifications, but as far as an LED indicator, I'm not aware of any special symbol. I've seen derivative/custom "plug" symbols, electric symbols (or other "lightning bolt"-type symbols), or even just an exclamation mark (!) used for this purpose, so I'm pretty sure as a UI indicator you can use whatever. ....just make certain you define it in accompanying documentation.