Every now and then, these questions come up:
- Which device information or parts of the device GUI must be translated?
- Do we need an ISO 13485 / ISO 17100 - certified supplier for translation?
Here comes a regulatory classic, as those questions are surprisingly hard to answer. Want to achieve 100% regulatory compliance? Painful. Any possible shortcuts? Hm, let’s see…
Medical Device Translations: Here’s What Is Required
First of all, for all those looking for 100% compliance: yes, following the applicable regulatory requirements, you will have to translate large parts of the information around your device: the instructions for use (obviously), labeling, packaging and marketing material incl. website content, your declaration of conformity and yep, potentially also (parts of) your software user interface.
You can find the main requirements written down here (non-exclusively, I’m sure there’s additional guidance documents on this):
EU Regulation 2017/745 (MDR) Article 10, Paragraph 11
Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I [‘Labels and Instructions for Use’] in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.
EU Regulation 2021/2226 (Instructions for Use for Medical Devices) Article 5, Paragraph 11
(…) The instructions for use shall be available on their website in an official language of the Union determined by the Member State in which the device is made available to the user or patient
That means essentially: for every market in which your device is available in, you will need to read up on that country’s national medical device law to see what language they deemed appropriate. Obviously, that begs the next question: is there an overview somewhere? Answer: ….. meh.
Exceptions From The Rule: Instructions for Use and Safety-Related Information
Back in 2008, some Medical Device Expert Group tried to come up with an overview based on the MDD. If you are willing to spend money on this topic, you can also find more updated overviews online to purchase. The important fact is though: in several countries, national law may allow you to only translate certain parts of your device information.
In other words, you may be able to ignore the need for translations as long as you observe the following requirements:
- You translate a minimum subset of information, e.g. instructions for use or even safety-related instructions only, depending on the country. The rest of your device information can be kept in English or a language understood by your users.
- Your intended users are (healthcare) professionals who, as opposed to lay people, understand English (smirk).
As an example, take the latest version of the German Medical Device Law, adapted to the MDR. Paragraph 8 requires that the EU Declaration of Conformity must be available in German or English language. Other device information, however, can be kept in English or any other language easily understood by users as long as the intended users are exclusively professionals and as long as safety-related information is translated into German or the intended user’s language.
Translation Providers And More Requirements
Before you get too happy: note there’s still other, more implicit requirements for translations. Translated information must be validated (= IEC 62366 usability-tested) in every language to ensure that, according to the above MDR Art. 10 Para. 11, it is “clearly comprehensible” by users. You should further not forget to document translation-related risks in your risk file (ISO 14971) and follow up with those as part of your post-market surveillance activities.
It is also true that, if you outsource translations to a third party, this provider is most likely a critical supplier that provides services essential to your product’s safety and compliance. As part of your ISO 13485 purchasing process, you may prefer suppliers which themselves maintain a 13485-certified QMS. This is not a hard requirement though. You could simply write a translation process of your own which you apply and control internally to provide accurate translations.
Conclusion: 3 Steps for Translation Software as a Medical Device (SaMD)
In a nutshell, this is how I would go about it:
- Check the national law of the countries in which your product is available (or: in which your product has the most active users). You won’t get around that, unfortunately. For those countries, hope that you only have to translate safety-related information in the user manual.
- Write a short work instruction as part of your QMS to demonstrate how you ensure “safe” and accurate translations and do that work internally.
- Validate translations for every device as part of your usability tests and document translation errors as part of your risk management.
Still sounds like a lot of pain rather than a regulatory shortcut? Well, what I would not do is: pay lots of money to a third party for translations, create supplier evaluation documentation for that, and translate all information for all devices in all markets.