Medical Device Labelling requirements for Class II software

[sueliu - 2012]

I have a question regarding the medical device labelling.

ISO 13485 did not mention the requirement for labeling in detail. However, FDA has a few regulations regarding labeling, such as 21CFR 801, General Device Labeling and 21 CFR 820 QMS. Since we are a software company, I am wondering how we should implement this part. To my understanding, we need to have the following components included in the label:
• Name of the software
• Name and address of manufacturer
• The identifier of the device, eg. A number to distinguish the device from others
• Indications for use
• CE mark (since we sell it to Europe)
• Rx sign
However, the fact that the company distributes its product through web server (does not sell packaged software) makes this question even trickier. I am not sure where and how we should “label” the software before they are distributed. Do you have any suggestions for me to implement this part?

Any help is appreciated! Thanks

Sue

[blewispunk]

Good question Sue! I am not certain how to address this but I believe having the required labeling within the software would be sufficient (commonly in a Help - About menu) for software that is only distributed electronically. Also, you need to have instructions for use available with the software that should also have this labeling. These instructions can be provided electronically but must also be provided in print if requested by the user.

Between the instructions and other labeling in the software interface I think you can address all the requirements without issue.

[Nissim Shaked]

Hi Sueliu,

Since the topic that you are asking about is very specific
I would like to present to you a path that could give
more "light" toward the need answer

In EN 62304:2006 the issue of Medical Software "stand alone" is covered but
the labeling issue is not covered totally.

You can use as an alternative the attached flow chart to study which information sources are suggested by the CE for your topic.

Nissim

[sueliu - 2012]

I have asked the same question to a friend who works in Germany. The following are his answers. Just want to share with people who have similar questions as me.

Labelling for the EU consists of 4 major parts:
1. In the SW itself (e.g. About Dialog with Manufacturers Adress CE Label , EU Rep and Notified Body ID in case of Class I* or higher, and a reference to the applicable MDD )
2. The packaging (meaning box and CD) contains Identifier of the SW, Manufacturers Adress CE Label , EU Rep and Notified Body ID -- Talk to you NB / EU Rep whether you will need to apply the symbols according to ISO 980. Each NB / EU Rep has a different oppion on that.
3. Accompanying document such as : The Declaration of Conformity (DoC). Release Notes
4. User Manual and Safety Instructions.

[bio_subbu]

In Reply to Parent Post by sueliu

I have a question regarding the medical device labelling.

ISO 13485 did not mention the requirement for labeling in detail. However, FDA has a few regulations regarding labeling, such as 21CFR 801, General Device Labeling and 21 CFR 820 QMS. Since we are a software company, I am wondering how we should implement this part. To my understanding, we need to have the following components included in the label:
• Name of the software
• Name and address of manufacturer
• The identifier of the device, eg. A number to distinguish the device from others
• Indications for use
• CE mark (since we sell it to Europe)
• Rx sign
However, the fact that the company distributes its product through web server (does not sell packaged software) makes this question even trickier. I am not sure where and how we should “label” the software before they are distributed. Do you have any suggestions for me to implement this part?

Any help is appreciated! Thanks

Sue

Hi Sue

Under Directive 2007/47/EC, when your software is classified as a medical device, it is subject to the same medical device requirements as under MDD 93/42/EEC. Therefore the language requirement of MDD 93/42/EEC applies as per Annex I, 13.3 (Information supplied by the manufacturer) that includes such documentation provided electronically as IFU, operators manuals, installation manuals, packaging and labeling to name a few. Additionally, for software classified as a medical device under Directive 2007/47/EC, “information” includes GUI (Graphical User Interface), menus, dialog boxes, and error and status messages.

Also, member states may require the information, which must be made available to the user and the patient in accordance with Point 13.3 of Annex I, to be in their national languages, when a device reaches the final user.

S. Subramaniam