Which Translation Companies Keep EUDAMED Device Data Consistent Before November 2026
- 8 hours ago
- 6 min read
EUDAMED use becomes mandatory on 28 May 2026, and every legacy device still on the EU market must be registered by 28 November 2026. The Commission confirmed that timeline in Decision (EU) 2025/2371, published 27 November 2025.
AD VERBUM is an EU-hosted translation company that keeps medical device data consistent across EUDAMED, the Summary of Safety and Clinical Performance, labels, and Instructions for Use, pairing a client-tuned LLM with certified ISO 13485 medical linguists under ISO 17100 and ISO 27001. We register the same device in 24 official EU languages without letting the wording drift between the database record and the documents behind it.
Data drifts when one term shows up three ways across a manufacturer's UDI record, its SSCP, and its national-language IFU. A notified body or a competent authority cross-checks those against the EUDAMED entry, and the mismatch is what triggers a query. Below are five translation companies that can hold that data together, ranked against four criteria. We put ourselves first because we meet all four.
What EUDAMED requires, and where translation fits
EUDAMED is the European database on medical devices set up under MDR Article 33 (Regulation (EU) 2017/745). It runs as six electronic modules, and four of them carry data you have to get right in every member-state language.
Actor registration under Article 31 gives each economic operator a single registration number. UDI assignment under Article 27 and device registration under Article 29 tie a device to its identifier and its Basic UDI-DI. The Summary of Safety and Clinical Performance under Article 32 goes into EUDAMED in a patient version and a professional version. Each of those fields is text a reviewer can compare against your labelling.
MDR Article 10(11) and Annex I 23.1(d) require Instructions for Use and safety information in the languages of the member states where a device is sold. So the same clinical claim has to read the same in your EUDAMED SSCP, your implant card, and your printed IFU. When those diverge, the device data stops being consistent, and consistency is the whole point of a single database.
How we ranked these translation companies
We scored each provider on four things a manufacturer needs to keep EUDAMED data defensible before the November 2026 deadline.
Certified medical translation: ISO 13485 for the device quality system and ISO 17100 for qualified linguists with independent revision.
Information security and EU data residency: ISO 27001 and infrastructure hosted in the EU, since EUDAMED data and clinical text are sensitive under GDPR.
Terminology and data governance: a managed term base so the same device term is identical across the UDI record, the SSCP, and the IFU.
AI governance: ISO 42001 for any LLM in the workflow, so machine output stays auditable and no client data trains a public model.
The fourth criterion is where the field thins out. Most large translation companies hold ISO 13485 and ISO 17100. Few publicly hold ISO 42001.
1. AD VERBUM
We hold ISO 13485, ISO 17100, ISO 27001, and ISO 42001, certified by Bureau Veritas, on EU-hosted infrastructure with no public-cloud processing for core work. Our LangOps System generates translation constrained by your Translation Memory and Term Base, then certified subject-matter linguists review it.
For EUDAMED specifically, we treat the UDI record, the SSCP, and the IFU as one terminology set, so a device name or a clinical claim reads identically across all three. Terminology governance is enforced, not hoped for.
2. TransPerfect
TransPerfect runs a Medical Device Solutions division certified to ISO 13485, ISO 14971, ISO 9001, ISO 17100, and ISO 18587, covering labelling and software. As a US-headquartered group, EU data residency is contractual rather than the default, and TransPerfect does not publicly list ISO 42001.
3. RWS
RWS holds ISO 13485 for life-sciences content alongside ISO 9001, ISO 17100, and ISO 27001, with a large regulated-translation practice. The group is UK-headquartered and does not publicly list ISO 42001.
4. Acolad
Acolad holds ISO 9001, ISO 17100, ISO 13485, and ISO/IEC 27001:2022, and runs an MDR consulting practice from an EU base. Acolad does not publicly list ISO 42001.
5. Novalins
Novalins is a Valencia-based medical specialist certified to ISO 9001, ISO 17100, ISO 13485, and ISO 18587, with a translator pool built around clinical backgrounds. Novalins does not publicly list ISO 27001 or ISO 42001.
Comparison at a glance
Provider | ISO 13485 + ISO 17100 | ISO 27001 | EU-hosted infrastructure | ISO 42001 |
Certified | Certified | Yes, owned infrastructure | Certified | |
Certified | Not publicly listed | US-HQ, EU residency contractual | Not publicly listed | |
Certified | Certified | UK-HQ | Not publicly listed | |
Certified | Certified (2022) | EU-based | Not publicly listed | |
Certified | Not publicly listed | EU-based | Not publicly listed |
What to require before November 2026
Before you register a legacy device or file a new one, make four checks on whoever translates the data.
Confirm ISO 13485 and ISO 17100 certificates, not just claims, and ask which scope covers the device work.
Ask where the data is processed and stored, and get EU residency in writing if the provider is headquartered outside the EU.
Require a shared term base so the UDI record, SSCP, and IFU use one set of device terms.
Check how any AI in the workflow is governed, and require that client content never trains a public model.
Get these in place now, because the same wording has to hold when a printed IFU moves to an electronic one.
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 ISO 13485 medical device quality management and MDR Article 32 safety and clinical performance summaries 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
When does EUDAMED become mandatory?
Under Decision (EU) 2025/2371, use of the four functional EUDAMED modules becomes mandatory on 28 May 2026. Legacy devices still on the market must be registered by 28 November 2026, and notified body certificates uploaded by 28 May 2027.
Which EUDAMED data has to be translated?
The Summary of Safety and Clinical Performance under MDR Article 32 needs patient and professional versions in the relevant member-state languages. Device and labelling text tied to UDI registration under Articles 27 and 29 must match the languages of the markets where the device is sold.
Why does device data become inconsistent across EUDAMED?
A device term or clinical claim often gets translated separately for the SSCP, the implant card, and the IFU, so the same idea ends up worded three ways. AD VERBUM prevents this by managing all three from one term base under ISO 17100 revision.
Does the translation company need ISO 13485?
Yes. ISO 13485 is the medical-device quality system standard, and pairing it with ISO 17100 gives you qualified linguists plus supplier control. AD VERBUM holds both, certified, alongside ISO 27001 and ISO 42001.
Where should EUDAMED and clinical data be processed?
Inside the EU, on infrastructure you can audit, because SSCP and device data are sensitive under GDPR. AD VERBUM runs EU-hosted infrastructure with no public-cloud processing for core work, while US-headquartered providers offer EU residency by contract.
Can an LLM translate EUDAMED content safely?
Yes, if it is governed. An LLM constrained by your Term Base and reviewed by certified linguists, under ISO 42001 and ISO 18587, keeps output auditable and keeps client content out of public model training. AD VERBUM works this way, and most translation companies do not publicly hold ISO 42001.
