Medical Device Label Revision Level Requirements

robert.beck

Involved In Discussions
#1
does anyone know if there is a requirement to display the revision level of a label on the label itself. or as a related question, is there a concise listing of what is supposed to be on a typical class II device label. I'm familiar with section 7.2.2 of IEC 60601-1 3rd edition, but apparently that's not the whole story.
 
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somashekar

Staff member
Super Moderator
#2
does anyone know if there is a requirement to display the revision level of a label on the label itself. or as a related question, is there a concise listing of what is supposed to be on a typical class II device label. I'm familiar with section 7.2.2 of IEC 60601-1 3rd edition, but apparently that's not the whole story.
Where appropriate, the instructions for use must contain the following
particulars:
(q) date of issue or the latest revision of the instructions for use.
MDD 93/42/EEC in the essential requirements tells this above.

This goes for the IFU. If your label does have an IFU information better you follow this rule.
 
M

MIREGMGR

#3
does anyone know if there is a requirement to display the revision level of a label on the label itself.
I agree with Somashekar in regard to IFUs.

More generally--both the FDA and EU regulatory systems require effective document and production controls. If you have a revision system, it's implied that label changes can occur and probably have occurred. If change has occurred, how do you know, and how would you prove to an internal or external auditor, that the right label is on the part if the label does not contain a version identifying number for itself as a part?

is there a concise listing of what is supposed to be on a typical class II device label.
Two part answer:

1. IEC 60601 is a technical standard. In my view, labeling of medical devices should start with the applicable medical device regulatory systems, i.e. US FDA, EU MDD, etc.

2. Direct answer to your question: yes and no. Such a list will depend on the nature of the device. So, start with the device and decide what's needed from that. The applicable regulations include guidances...become familiar with those, and it's straightforward.
 

robert.beck

Involved In Discussions
#4
thanks. That's a given for the IFU. I'm asking about the label, not the IFU. This problem arose during an audit to 60601-1 3rd edition. When I asked someone knowledgeable about FDA regulations, she told me that the revision level of the label was required to be on the label, per regulation. I'm trying to track down that regulation. This requirement is not in the 60601-1 3rd edition standard's section for label requirements.
 
#5
As Somashekar suggests it is possible to consider the labeling as being part of the IfU.

If your label states "Push this" or "Don't push here" it is, in effect, Instructions for Use. As such it would require the date / issue.

FDA consider all labels and IfU (and advertising) as "labelling".
 
M

MIREGMGR

#6
I'm trying to track down that regulation.
The concept of part identification and control as a key element of good manufacturing practice is present throughout US FDA's rules and guidances. See for instance 21CFR 820.60 Identification, 820.70 Production and Process Controls, and 820.40 Document Controls.

All of FDA's label/labeling guidances assume that labels will be controlled via some sort of part identification system, providing for revision identification if revisions are possible. See for instance "Labeling--Regulatory Requirements for Medical Devices", p. 22. A list of all FDA device labeling guidances can be found in "Device Advice--Introduction to Medical Device Labeling".
 

robert.beck

Involved In Discussions
#7
thanks. the 60601-1 test house doesn't agree with you about labels. i've had at least six label-related issues to deal with. I found them to be correct on two, and wrong on the others.

i'm glad that someone thinks this is straightforward. Unfortunately, I don't find it simple to identify the 'applicable' regulations nor to locate their guidances.

however, the part of your answer that starts with, "More generally" tells me how to deal with this situation. someone told me that there is a "regulation" that requires the label revision number to be displayed on the label. I don't believe there is such a specific regulation, but in the context of maintaining revision control and traceability, it makes sense that it is required as part of production control.
 

robert.beck

Involved In Discussions
#9
Good answer. I downloaded all of the guidance documents. too much to absorb all at once, but page 22 is exactly the answer I was looking for (this time!).
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Hi,

I currently can't remember a specific regulation requiring the label to show the revision level (when it can't be considered IFU). However, labels are (or at least ought to be) controlled documents, and as such I would expect them to show the revision level. Perhaps your answer hides in the Document Control regulations and/ot guidance.

I don't particularly agree that a label should bear the revision level (or even any identification marks), just because it's a medical device component, or even a very important one. Of course this could make a lot of sense, but I'm not currently aware of a related regulatory requirement across the board. For instance, many plastic parts of many devices bear no identification marks, even though their design is controlled and they go through numerous and/or frequent design revisions. Such parts are controlled and implementation of the current revision is ensured via a host of means, according to the criticality / possibility of getting it wrong. So in theory the same could be done with labels.

In fact, in the pharma industry it's a common requirement that the labels issued for each and every batch are visually proofed by more than one competent person against the current master, to make sure that no discrepancies are present, for whatever reason (including using an outdated revision). The typical instructions require visual inspection of all details to ensure that they are identical; this goes well beyond just verifying the revision level.

Cheers,
Ronen.
 
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