Question 1

Do we need translations for IFUs/labels under MDR/IVDR?

Accepted Answer

Yes. Both the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) require that Instructions for Use (IFUs), labels, and safety information be provided in the official language(s) of each EU member state where the device is marketed. Non-compliance can result in delayed approvals, product recalls, or market access restrictions.

Question 2

Which countries/languages are mandatory?

Accepted Answer

Language requirements depend on the target market. In the EU, each member state has specific rules (e.g., Germany requires German; France requires French; Belgium requires Dutch and French, sometimes German). Switzerland and EFTA states generally align with EU requirements. Other global markets vary—for example, Canada requires English and French and China requires Simplified Chinese. As a rule of thumb, regulatory and safety information must appear in the official language(s) of the country where the device is sold.

Question 3

Can you translate software UIs/e-IFUs?

Accepted Answer

Yes. We translate software user interfaces (UIs), e-IFUs, and digital labeling in compliance with MDR/IVDR, including on-screen menus, help files, patient-facing portals, and electronic IFUs. Our process supports linguistic accuracy, regulatory compliance, and user-friendly terminology for usability studies and CE marking.

Question 4

What standards do your translators follow (ISO 17100, medical SME review)?

Accepted Answer

Our medical device translations follow ISO 17100, which requires qualified native-speaking translators, an independent second-linguist review, and documented workflows with terminology management. For highly technical or high-risk content we can add medical SME review to validate terminology, and align with MDR/IVDR and FDA expectations.

Question 5

Can you tell me about typical timelines & quality controls (TEP, back-translation, bilingual review)?

Accepted Answer

Standard projects such as labels and IFUs are typically completed within 5–10 business days, with expedited options available. Larger deliverables (e.g., CERs or PMS reports) can take longer. Quality controls include a TEP workflow (translation, editing, proofreading), optional bilingual or in-country SME review, optional back-translation for high-risk documentation, and customized terminology/style guides for consistency.

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The team was great to work with - they were understanding of our needs and turned around our translation pieces quickly.

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