Is it ok to provide a different language upon request?

[Mark Meer]

Article 10 of the EU MDR states:

11. Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient.

(emphasis added)

Here's the scenario:
- We have translated labelling for each EU country we ship to, in order to comply with this regulation.
- Now, one of our distributors is requesting that we send them a shipment with English labeling - not the language of their member state (presumably because they have some English-speaking customers in the country).

Questions:
- If we were to comply, would we be violating the regulation?
- If so, is there some other strategy by which we can comply with their request (maybe designating it as custom?).
- Am I over-thinking? Is this even a big deal to comply with the distributor's request and ship them an English package?

Any input/advice much appreciated!
MM.

 

[Ninja]

#1: I am not in medical...so read this with that in mind...

The requirement seems pretty clear..."in an official Union language(s) determined by the Member State in which the device is made available to the user or patient".
If you or your distributor want to ADD english, so be it...but it does not remove the foundation requirement.

The only way the base requirement would be bypassed is if the location where "the device is made available to the user or patient" is not a member state...

Then you would have to look into the regulations of that new area.

HTH

 

[Mark Meer]

The requirement seems pretty clear..."in an official Union language(s) determined by the Member State in which the device is made available to the user or patient".
If you or your distributor want to ADD english, so be it...but it does not remove the foundation requirement. ...

Thanks for the input Ninja.

I agree, but to clarify: it is not that English is added, they are requesting a shipment that is only English (because there are some labels (packaging, device,...) that space-wise it is not possible to have more than one language).

That being my situation, let's expand to a hypothetical to further discussion:

What if the EU distributor has some in-country customers that don't speak any official EU languages - say, they speak Arabic. They put in a request to the manufacturer - who already sells in the UAE so has already developed Arabic labelling - to ship them the Arabic versions of their product. Can the manufacturer comply with such a request? How does this situation change if the language IS an official EU language, but NOT a language of the specific member state?

 

[Ninja]

Again, I'm not in medical...so take anything I say as unreliable third party...

"They put in a request to the manufacturer - who already sells in the UAE so has already developed Arabic labelling - to ship them the Arabic versions of their product."
---asking is one thing, disobeying a directive is another...that's why I used the word "add". Add Arabic if desired, but you still have to comply with the requirement to provide language selected by the member state.

"Can the manufacturer comply with such a request?"
Sure...they can ADD the language. It does not, however, release them from the existing burden to supply the "official Union language(s) determined by the Member State".

"How does this situation change if the language IS an official EU language, but NOT a language of the specific member state?"
It doesn't. You have a regulatory obligation defined by the specific member state. You can do whatever you want IN ADDITION to that...but you still have to do what the member state defined, and that the standard requires.

The end user ( I assume) does not have the authority to override regulatory requirements.

Separate it out for me in the USA (in extreme intentionally). If a customer wants me to ship a topological poison to them, but add language to the label stating that is is a hair dye...I can add whatever label I want, but it will IN ADDITION get a skull and crossed bones with the words "Poison, do not ingest. Avoid Skin Contact. Use with Care. TOPOLOGICAL POISON." on it, as well as all of the other required warnings.

FWIW, there are a variety of expandable labels, and a variety of sizes in warning brochures...everything is available at a price...

HTH

 

[Mark Meer]

...
"Can the manufacturer comply with such a request?"
Sure...they can ADD the language....

Yes, of course. But this would burden on the manufacturer. Instead of simply shipping an existing ready-to-go product (e.g. the Arabic version), they'd have to develop entirely new labelling (German/Arabic, French/Arabic,...). That is to say nothing of those labels inherently restricted by space...
In all likelihood, in the end, the distributor would have to report to their Arabic customers that they are S.O.L.. Seems a shame...

The end user ( I assume) does not have the authority to override regulatory requirements.

Separate it out for me in the USA (in extreme intentionally). If a customer wants me to ship a topological poison to them, but add language to the label stating that is is a hair dye...I can add whatever label I want, but it will IN ADDITION get a skull and crossed bones with the words "Poison, do not ingest. Avoid Skin Contact. Use with Care. TOPOLOGICAL POISON." on it, as well as all of the other required warnings.

I don't know that this is a fair comparison, as what the customer is requesting is arguably something to help them use the device as intended, and more safely.

If a customer is not well versed in the native language, there are only a few options:

1. Ask manufacturer to make new labels that include their language
- Likely outcome: too burdensome for manufacturer and they refuse. Customer does not get their medical device.

2. Ask manufacturer to ship the device in their language (assuming the manufacturer already has such unit available).
- Likely outcome: manufacturer refuses as it would violate regulations. Customer does not get their medical device.

3. Ship in the available EU Member State language
- Likely outcome: customer receives device, but may not use correctly/safely as they might not be able to properly interpret the labelling.

None of these likely outcomes seems all that great...

 

[Marcelo]

- If we were to comply, would we be violating the regulation?

Probably yes.

For example, Brazil has requirements that the instructions for use (or any labeling) are in Portuguese. Any device put into the country (in Brazil's case, it's not only into the market, but into the country) that does not come with instructions for use (or labeling) in Portuguese is violating the regulation. If a distributor requests that a manufacturer send them device with instructions for use in English, the manufacturer would in principle need to say that he cannot ship a device with that characteristic. If an ANVISA officer in customs notes a device with instructions for use (or labeling) not in Portuguese, he can deny it's entry into Brazil.

 

[Mark Meer]

...If a distributor requests that a manufacturer send them device with instructions for use in English, the manufacturer would in principle need to say that he cannot ship a device with that characteristic. If an ANVISA officer in customs notes a device with instructions for use (or labeling) not in Portuguese, he can deny it's entry into Brazil.

This is what I suspected (sadly).

...but I predict that in the near future this approach will become increasingly untenable.

As countries become increasingly multi-cultural there are growing segments of local population whose grasp of the official language is minimal, and for whom such policies are inadvertently detrimental.

 

[dgrainger]

Under MDR the distributor has to verify that the manufacturer is meeting Article 10(11) - they can't request extra languages! See Article 14.2.(b)

 

[ScottK]

wait wait wait

I was in printing for a time. We printed IFU sheets in multiple languages for our customers. In the same document. So something going to France came with instructions in English, French, Spanish, German, Dutch, and Italian - all in one document. That way they only had to print a single document and keep inventory of a single document.

I don't believe this is in violation of the directive.
If it's not then sending a customer a document in another language would be fine as long as they also have it in the language of their state as required by the directive.

 

[dgrainger]

Whilst probably ok for the IFU, the question is about labeling on the device.