We are in the process of identifying label language requirements for medical devices marketed to the EU and other global locations. The bottom line for label language requirement determination appears to be whether or not a given country has promulgated such requirements into their National Law. This is quite clear.

What is not so clear is the scope of where "label" language issues start and where they stop. For example, our device has at least for areas of concern:

1. The actual physical labeling applied to the packaging and the product.

2. A User's Manual which is provided electronically on a CD.

3. The "Help" functions embedded in the installed software (our device has a PC "control station")

4. The User Interface, e.g. the keyboard, the operating system, etc.

Clearly, some of these areas would require extensive revision if they were/are to be included in any national language requirement.

Does anyone have any feedback or experience in this regard?

Thanks,

Steve

Possibly this thread CE Language Requirements on labeling (both device and packaging) (http://elsmar.com/Forums/showthread.php?t=10767) is related to your inquiry.

We are in the process of identifying label language requirements for medical devices marketed to the EU and other global locations. The bottom line for label language requirement determination appears to be whether or not a given country has promulgated such requirements into their National Law. This is quite clear.

What is not so clear is the scope of where "label" language issues start and where they stop. For example, our device has at least for areas of concern:

1. The actual physical labeling applied to the packaging and the product.

2. A User's Manual which is provided electronically on a CD.

3. The "Help" functions embedded in the installed software (our device has a PC "control station")

4. The User Interface, e.g. the keyboard, the operating system, etc.

Clearly, some of these areas would require extensive revision if they were/are to be included in any national language requirement.

Does anyone have any feedback or experience in this regard?

Thanks,

Steve
Language requirement applies to all information provided for the safe and effective use of the medical device. To a large extent you can reduce words and use recognized symbols per the standard EN 980. Since you are based in USA, I am sure you will have appointed your EU authorized Rep in Europe. He could provide you the language requirements of all EU countries. Please be aware that one or several EU languages are acceptable in EU countries. Now based on your product placement strategy, a good combination of all languages can be arrived at, and your user instructions can be in them which is acceptable in your target market region. Again here use of symbols can to a great extent reduce the volume burden. Still no wonder that the IFU's are indeed getting fatter, courtesy languages in EU.

Yes, we are working directly with our AR in the EU with these questions. Unfortunately, very few of the countries have promulgated national language laws with this degree of specificity.

Practically speaking, the efforts required to provide labels & users manual into a local language is one thing. Providing this same approach to the UI (user interface) is a wholly different matter. Consider keyboard characters, software screen shots - and most importantly the OS (operating system) of a PC. What are my chances of getting Microsoft to develop an affordable OS in...Farsi!?

Hence, the need for specificity in the interpretation of existing laws. BTW, I see your location is India. If I sell a medical device to a customer in India what are the laws regarding label language, keyboards, user interface, etc?

One other quick note...

The document you are referring to is EN 980 that speaks to symbology. That having been said, another contributor to the Cove just related an instance where FDA stopped processing his 510(k) submission for lack of English language text to accompany a symbol. E.g., the "Manufacturer" symbol would have to be accompanied by the word "Manufacturer"!

English is pretty much OK here in India for medical devices.... There is no local language requirement as such for medical as my understanding goes.

Interesting. But if I wanted to verify that this was indeed the case, where would I go to locate and document that verification? (FDAspeak: "if it isn't documented it isn't done...")

Interesting. But if I wanted to verify that this was indeed the case, where would I go to locate and document that verification? (FDAspeak: "if it isn't documented it isn't done...")
cdsco.nic.in
First find if it governs to your type of medical device .....

This page (http://www.ita.doc.gov/td/health/regulations.html) from the US Commerce Department provides summaries of national medical device regulations for a number of nations. However, most of the information is pretty sparse. It might give you some further leads in some cases.

For instance, a nation such as Jordan that accepts medical devices that are legal for sale in the US, the EU or Japan, by implication must be willing to accept (and de facto probably expects or even insists upon) the sole interface language being standard medical English.

Here's (http://www.devicelink.com/mddi/archive/07/01/008.html) another summary of Asian regulatory requirements that is more up to date, and seems to have been written by someone that understands medical device marketing.

Obviously a hot topic.

We have sold in many EMEA & APAC regions, but have been under the gun to place language on each medical device we manufacture. Problem is labels on the outside are easy, the localized language setting for software is still an issue. It was ‘suggested’ that we even change the OS for the PC we provide for our device. That is going rather afar, given that our device is in US-en, and most customers who want it understand, read and speak English. It was also noted that we include ALL possible languages on the eternal labels; so in Switzerland we would need German/French/English/Swiss-dialect to pass registration.

We designed a large family of labels for pouched sterile disposables, generally compliant with FDA and EU MDD regulation and CE marked, for a worldwide OEM. Most of the label's information is in standard symbols or English, but they wanted the "Sterility is guaranteed unless package is damaged or seal is broken" statement additionally expressed in French, German, Italian and Spanish. The products also carry re-order telephone numbers for 23 national offices, plus the central numbers for USA and Canada.

Fortunately, the products themselves carried no language-communications and, of course, no software to be localized.

We manufacture a costly & complex Class II (EU IIa) device & wrestle with this same issue - at all levels.

To begin with, there is no universal "clearinghouse" for label language requirements. One must go to the Competent Authority in each EU and search the appropriate National Legislation regarding label language requirements for medical devices. Outside the EU, it even more of a Google-intensive search process.

Next, one needs to investigate whether or not these language requirements have any degree of specificity. In our case, we need to address "label/labeling" issues in the following areas:

1-Physical labels on the product and the packaging
2-User manuals in all printed and electronic medias
3-I/O device, e.g. keyboard
4-OS (over which most manufacturers have zero control)
5-UI (over which the manufacturer has full control)

So, if anyone has better sources for information of this type with this degree of specificity this would be worth its weight in gold!