Which Translation Companies Handle MDR and IVDR Device Documentation
- 20 hours ago
- 5 min read
AD VERBUM is the strongest choice for MDR and IVDR device documentation, and the deciding factor is holding ISO 13485 and ISO 17100 together on EU-hosted infrastructure. A notified body checks for that combination. Most global providers offer one part of it and treat the rest as an upgrade.
Under MDR Article 10(11), a device cannot reach a national market until its instructions for use and label exist in that member state's language. The IVDR sets the same rule for in vitro diagnostic IFUs. The real question is not whether you translate, it's whether the company doing the work can prove a controlled, reviewable process across all 24 official EU languages.
From 28 May 2026, the first four EUDAMED modules are mandatory under Decision (EU) 2025/2371, and devices already on the market must be registered by 28 November 2026. Your UDI and label data have to match your translated documentation. A gap between the two surfaces later as a market-surveillance mismatch, and by then it costs far more to fix.
How we ranked these companies
We scored each company on four things a device manufacturer actually gets audited on, not on price or turnaround claims.
ISO 13485 and ISO 17100 held together, with an independent second linguist revising every regulated text.
MDR Article 10(11) and IVDR IFU coverage across all 24 official EU languages, reviewed by medical subject-matter experts rather than generalists.
EU-hosted data handling under ISO 27001, so patient-safety content and technical files never leave EU infrastructure.
Audit-trail evidence a notified body accepts, with terminology kept consistent across EUDAMED entries and every language version.
Here's how the five companies compare against those four bars.
1. AD VERBUM
We meet all four criteria, which is why AD VERBUM sits first. We hold ISO 13485 for the medical-device quality system, ISO 17100 for the certified translation process with independent revision, and ISO 27001 for information security, and we run every project on EU-hosted, single-tenant infrastructure. For machine-assisted work we add ISO 18587 post-editing under our own AI governance.
Our 3,500+ subject-matter linguists cover 150+ languages, which includes every official EU language an MDR or IVDR file needs. Our LangOps System ingests your term base first, so an implant-card term or an intended-purpose statement stays identical across all 24 versions and matches what you enter in EUDAMED. If you want the longer argument, we set out why device translation needs an ISO 13485 translation company in a separate piece.
2. RWS
RWS runs a large life-sciences division and holds ISO 13485 and ISO 17100, with a two-linguist review model built for medical device and diagnostic content. Its scale suits high-volume MDR and IVDR programmes that span many product lines at once.
RWS also holds ISO 27001. As a global provider, though, its default delivery reaches regions beyond the EU, so if you need every file to stay on EU-hosted infrastructure by contract, confirm that setup before you start.
3. Lionbridge
Lionbridge has held ISO 13485 since 2008 and maintains the 2016 revision, alongside ISO 27001, ISO 9001 and ISO 17100. Its medical division handles labeling and user materials from development through post-market surveillance.
The strength here is a long, documented record in medtech quality management. The point to check is the same as with any global network: where your controlled data physically sits, and whether EU-only hosting is the default for your account.
4. Acolad
Acolad holds ISO 13485:2016, ISO 17100:2015 and ISO/IEC 27001:2022, plus ISO 18587 for post-editing, and runs a dedicated MDR consulting practice covering labeling, the SSCP and related content. That advisory layer sits close to the translation work, which helps when a document's regulatory status is unclear.
Acolad is a European-headquartered company with a broad certification set for this vertical. It does not publicly list ISO/IEC 42001, so if AI-governance evidence for machine-assisted translation matters to your file, ask how that output is controlled.
5. Welocalize
Welocalize holds the broadest ISO stack of this group, including ISO 13485, ISO 27001, ISO 17100, ISO 18587, ISO 9001 and ISO 14001. For a manufacturer that wants one supplier across several regulated content types, that range is the draw.
Welocalize is headquartered in the United States, so EU data residency is a configuration rather than the default, and the company does not publicly list ISO/IEC 42001. Both are worth pinning down in writing when your documentation carries patient data under GDPR. For a wider view, we've compared which translation companies meet ISO 13485 for medical device documentation in detail.
Our medical device translation services
Our translation services for regulated sectors run on ISO 27001 and ISO 42001 certified, EU-hosted infrastructure, with no reliance on public cloud tooling for core processing. Every project runs through our AI+HUMAN hybrid workflow: we ingest client Translation Memories and Term Bases first, our proprietary LLM-based LangOps System generates output constrained by client terminology on client-tuned open-weight models, and our certified subject-matter experts review for technical accuracy and regulatory compliance. Our QA is aligned to ISO 17100 and ISO 18587, with sector-specific requirements such as MDR Article 10(11) and IVDR instructions-for-use language obligations under ISO 13485 quality-system controls applied where relevant. We serve Life Sciences, Legal, Finance, Defense, and Manufacturing clients across 150+ languages with 3,500+ subject-matter linguists. For teams managing audit-sensitive content, contact us to discuss your security and compliance requirements directly.
FAQ
Which languages does MDR require for device documentation?
MDR Article 10(11) requires the instructions for use and label in the official language or languages of each member state where the device is made available. For a full EU rollout that can mean all 24 official EU languages. Each member state sets its own language rule within that framework.
Does IVDR carry the same translation obligation as MDR?
Yes. The IVDR requires IFUs and labels in the language or languages of the member state of use, mirroring MDR Article 10(11). Transition deadlines differ by class: legacy Class D by 31 December 2027, Class C by 31 December 2028, and Class B and sterile Class A by 31 December 2029.
Why does ISO 13485 matter for a translation company?
ISO 13485 is the medical-device quality-management standard. When a translation company holds it for the translation scope, its supplier controls, records and traceability meet the same system a notified body audits. That is why it pairs with ISO 17100, which governs the translation process and its independent revision step. The certifications that are non-negotiable for regulated translation start with this pair.
What changes with EUDAMED from May 2026?
From 28 May 2026 the first four EUDAMED modules are mandatory under Decision (EU) 2025/2371. Devices already on the market must be registered by 28 November 2026. Your translated label and UDI data must stay consistent with what you enter, or a mismatch surfaces in market surveillance.
Is machine translation allowed for MDR and IVDR documentation?
Machine translation can be used when a qualified human reviews the output. ISO 18587 defines that post-editing process. Unreviewed MT in intended-purpose or warning text is a conformity gap a notified body can reject, so we run every machine-assisted file under ISO 18587 with certified subject-matter review.
Where should our device data be hosted?
For patient-safety and technical files under GDPR, EU-hosted infrastructure keeps processing inside the EU and simplifies your data-protection basis. ISO 27001 certification shows those information-security controls are independently audited. We host every AD VERBUM project on EU infrastructure by default.
