Medical Device Language Translation Requirements

P

pobbyree79

#1
First of all, let me start off by saying I'm not a regulatory expert by any means. I work for a medical device manufacturer that sells product to distributors for distribution all across the EU. The product that we distribute is a line of disposable, single use equipment covers (sterilized) within a pouch. I have been told that our labeling must accomodate 23 languages as well as some international symbols such as "Do Not Reuse".

Some of our equipment covers go within a 6" x 10" pouch and get labeled on the outside appropriately. We have discovered that it is almost impossible to label such a small area with such a large amount of information. I've been told it's mandatory to label at the pouch (and not just box) level.

I am wondering if somebody can confirm or point me in the right direction on the EU / CE Mark label language translation requirements. I find it difficult to understand how so much language translation needs to fit on individual packaging for the operating room for medical devices. Before we go down this road I'd like to feel confident that the information I've been given is correct.

I thank you in advance.
 
Elsmar Forum Sponsor
#3
Hello and welcome to the forums.

The labeling that you require is detailed in Annex 1 of the Medical Device Directive 93/42. Annex 1 is the Essential Requirements and part 13 of that is titled "Information supplied by the manufacturer". This covers your pack labeling and the information that you supply in the Instructions for use (IfU).

Because Europe has many languages the general approach is to use standardised symbols where possible. So, for instance, there is a symbol for "Do not reuse" (a crossed out 2 in a circle). The standard for the symbols is EN 980.

The directive accepts that small devices cannot carry as much information as big ones. Generally, on the pack you would need things like product identification, manufacturer address, lot number, sterilisation expiry date etc whilst the details of how to actually use the product would be in the IfU.

Language requirements for the IfU tend to vary from country to country. Most of the "large" European countries demand local language, but some of the smaller nations allow English only, particularly for devices that are only for professional use.
 

chris1price

Trusted Information Resource
#4
Hi

There are a few things that can minimise the amount of work required. As stated above, work out from the Essential Requirements what information is required and use the Harmonized Symbols wherever possible. Where translation is needed, it is only required for those countries where the product is actually sold.

IFUs are not required for Class 1 and 2a devices if they can be safely used without such instructions. If you choose not to supply an IFU, this should be documented in your risk analysis.

Also, check competitor product and see what they do. Don't always assume they are correct, but it should give you an example to work from.

Chris
 
P

pobbyree79

#5
All,

Thank you very much for taking the time to reply. I don't know if the products we sell are classified as IIa or IIb, but I will investigate. We are using the symbols when possible and currently translate product descriptions in at least 23 languages since our distributors could literally sell anywhere in the EU.

Again, I appreciate your responses.
 
P

pobbyree79

#6
I would like to add all of our "medical devices" are classified as 1s and below. We have determined that we can document our risk analysis with the use of ther International symbology to leave English only on the pouched product while referencing a box label that has all of the needed EU language translations for product descriptions.

I am being told that it is MANDATORY to have product descriptions translated, but we've been shipping product to the EU for a number of years without it and have not had a single issue. They are professional use devices with very little risk (if the product doesn't fit the equipment you get a new one).

I would argue that by using the SKU number to identify product that the product description doesn't need to be translated and thus we can continue to sell our product in English only due to its lack of risk. Would you agree, or is translation indeed mandatory?

I thank you again for your time.
 
M

MIREGMGR

#7
A number of the transposition laws state that devices marketed in Country X must be labeled in national-languages-for-X. A few EU countries allow English-without-national-languages for professional use devices. My understanding is that the current consensus is that 23 languages are required on professional use devices. This ignores the Candidate Countries for which the language legal status is unclear, at least for me.

My understanding is that there's no provision in any of the transposition laws of the language requirement being subject to device-marketer judgement as to applicability, based on a risk rationalization.
 
#8
".............the SKU number"

If SKU means Stock Keeping Number how is that supposed to help a clinician (scrubbed up in theatre) identify the device? I don't think it would be valid to think that they would have access to a catalogue (printed or on-line) nor would it be reasonable to think that they remember different stock numbers.

Presumably they are actually identifying different models simply by looking at them through clear packaging. Perhaps the critical pack information is a size (mm or Fr) which is not language dependent?

Years of problem free use are great, but that does not necessarily mean that your device is either correctly marked or that things will continue always to be OK. I often see devices "out there" that I wonder how they are allowed to be marketed.
 
A

asimuh

#9
Poosible approach:


1. Use your risk analysis to identify the scope of your manual (do you need 1000 words or 1000000 words?? depend on the risks. Also double check with EN 1041 and EN 980.

2. Google following to find the applicable requirements regarding translations:

MDEG_-_2008-12_-_II-6.3._Mandatory_Languages_Requirements_for_Medical_Devices_update_Sept.08[1]

3. If it is a legacy product and it will take long time to translate, then agree upon an action plan together with your notified body.
 
P

pobbyree79

#10
My understanding is that a general bill of materials list is created for an operation. This BOM would reference the proper product identification number to be pulled and staged for the operation. By matching the numbers in stock with the number on the BOM list I would think it would suffice. Obviously not everything is immediately planned, nor is every facility operating under the same procedures, but I don't think it would necessarily be good practice to randomly read product on a shelf until you came to one you thought would work.

I appreciate all of your feedback. We are forging ahead with the language requirements for all of the EU territories.
 
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