How to best prioritize Medical Device Label Contents

[Mark Meer]

Hi Everyone!

A little bit of a dilemma here: we have a small, home-use, wireless medical device and are in the process of developing the device labels.

We'd like to have a single device label that complies with US, EEA and Canadian regs, and additionally get certified to IEC 60601-1, 60601-1-2 and 60601-1-11.

This makes for a lot of required info! Too much to fit to be sure (our allocated label-space is about the size of your thumb)...

So, I'm wondering if anyone has any input on what is "absolutely essential" and what can be relocated (e.g. to IFU)...

Here's the list of label requirements so far (please let me know if I'm misinterpreting regulation/standards, or if I've missed anything):

The ones I'm pretty sure are required:

• General
  • IP Rating (required by IEC 60601-1-11 clause 7.2)
  • Consult Instructions symbol (recommended by IEC 60601-1 clause 7.2.3)
  • Applied Part symbol (required by IEC 60601-1 clause 7.2.10)
• Identification
  • Name and address of manufacturer (required by MDD clause 13.3a)
  • Unique device identifier (required by FDA 21 CFR Part 801)
  • Year of manufacture (required by MDD clause 13.3l)
  • Lot Number
  • Serial Number
  • Model Number
  • GTIN (required because UDI must also include a human-readable format)
  • Label ID & Revision
• Because it has a radio:
  • Non-Ionizing Radiation symbol (required by IEC 60601-1-2 clause 5.1.2)
  • FCC ID (required by US FCC)
  • IC ID (required by Industry Canada)

Shortlist: Ones that either would be nice to include, or I'm not sure about...

• "Rx Only" (it is a prescription device for US....can't find and explicit regulation requiring this though...)
• NRTL Mark
• CE Mark
• WEEE Symbol (WEEE Directive 2012-19-EU)

Anyway, obviously all of the above are next to impossible to cram into our label space (we can rule out laser-etching or other fancy stuff...we don't have the means).

So, seeking any advice on what (if anything) can be omitted from the device label (and moved to IFU and/or packaging).

Thanks in advance!

 

[Marcelo]

Re: How to best prioritize device label contents

Consult Instructions symbol (recommended by IEC 60601-1 clause 7.2.3)

What risk control measure will you use this to refer to?

 

[Marcelo]

Re: How to best prioritize device label contents

Anyway, ISO TC 210 has just decided to create a general labeling standard, maybe a problem like yours should be part of the document too as I see things like this questioned from time to time.

 

[Mark Meer]

What risk control measure will you use this to refer to?

I'm not quite sure what you mean. There are many warnings, precautions and contraindications that obviously cannot be stated on the label itself. So it seems prudent to indicate that the operator should first consult with the IFU.

To be honest, I was hoping that maybe using the Mandatory Action Symbol, ISO 7010-M002, might be a way to avoid having to cram the label.

ISO TC 210 has just decided to create a general labeling standard

That's great...provided it aligns with all the aforementioned regulations and standards. Unless it has some exceptions that supersede the requirements I've listed, however, I don't see it being much help in terms of "label-overload" problem I'm describing.

 

[Mark Meer]

Warning: Rant Time

I find this kind of label-cramming problem quite frustrating.

Like I say, we are dealing with label-space about the size of a thumb.

The GTIN is 14 characters, FCC ID up to 15 characters, IC ID up to 11 characters, date is 10 characters, lot is 8 characters, model is 5 characters, IP rating is 4 characters... That's 7 lines of text right there!

Now add to that all the required symbols: Applied Part, Non-Ionizing Radiation, UDI...

And THEN manufacturer information?!

For small labels, adhering to all these requirements quickly becomes ludicrous!

And for what? In practice few people know what symbols mean without consulting the descriptions in the IFU. And seriously...does the presence of, say, a "BF Applied Part" symbol really affect how people use the device?
Also, the requirement that UDI also has human-readable interpretation (HRI) seems of little value...

 

[Marcelo]

I'm not quite sure what you mean. There are many warnings, precautions and contraindications that obviously cannot be stated on the label itself. So it seems prudent to indicate that the operator should first consult with the IFU.

To be honest, I was hoping that maybe using the Mandatory Action Symbol, ISO 7010-M002, might be a way to avoid having to cram the label.

This symbol is to be used when there?s a link to a specific risk control measure for a specific risk, as defined in the rationale:

Subclause 7.2.3 ? Consult ACCOMPANYING DOCUMENTS
It is not intended in every case when the instructions for use contain warnings, that the ME EQUIPMENT be marked with ISO 7010-M002 (see Table D.2, safety sign 10). Too many warnings and unnecessary warnings are counterproductive. Only when the MANUFACTURER, as a RISK CONTROL measure for a specific RISK, decides to mark the ME EQUIPMENT to instruct the OPERATOR to read the instructions for use, should safety sign ISO 7010-M002 be used.

In previsous editions, this was not very clear so people understand that every time you had to put this symbol, which is stupid ("read the whole manual" is not a good reminder of risks). This also could cause even more risks.

 

[Marcelo]

And for what? In practice few people know what symbols mean without consulting the descriptions in the IFU. And seriously...does the presence of, say, a "BF Applied Part" symbol really affect how people use the device?

It?s more related to liability than anything else.

 

[pkost]

I'm not an expert on the US requirements (or electrical in general), however in the EU labelling the device does not always have to mean direct part marking; it can also be applied to the packaging.

In the past I have had to make similar decisions and did it on the basis of risk - what information is critical for safety (primarily), post market surveillance (secondary)

I ended up with all labelling on the primary packgaing and the LOT number on the device itself

 

[MIREGMGR]

Re: How to best prioritize device label contents

ISO TC 210 has just decided to create a general labeling standard

Is there more information available on this? Who from US FDA is participating?

 

[Marcelo]

Is there more information available on this? Who from US FDA is participating?

No, this was decided in the last plenary and initial work is being discussed.

No one is participating yet, but it was proposed by WG 2 - which is chaired by Carol Hermann from AAMI, with input from Dave Osbourne from Philips.