A Notified Body has queried an instruction for use during your CE marking submission. A competent authority has rejected an implant card during post-market surveillance. The regulatory submission you scoped six months ago is held at the last hurdle because the language scope went into the project plan after everything else had locked.
These scenarios share one cause. Translation got scoped at the wrong stage of the project, treated as a finishing step rather than as part of the regulatory deliverable. MDR translation requirements are the language obligations in Regulation (EU) 2017/745, primarily Article 10(11) and Annex I Section 23. They cover which medical device documents must be translated, into which official EU languages, and at what point in the CE marking process those translations need to be ready.
This guide is for the regulatory affairs lead, head of localisation, or quality manager evaluating whether their current supplier handles MDR work to the standard the regulation now demands. It gives you the document scope matrix, the member-state language map, and a vendor evaluation checklist that lifts into a supplier RFP. For the deeper read on quality methodology, see the AdHoc cluster piece on medical translation quality assurance, and for an overview of how we structure MDR-grade medical translation work, see our service page.
| TL;DR • Article 10(11) of Regulation (EU) 2017/745 plus Annex I Section 23 set the primary translation obligation: every device must be accompanied by labels, packaging, and IFUs in the official language(s) of the member state where it is sold. • Each member state sets its own requirement. About half require the national language for IFUs. The rest accept English for professional-use devices under specific conditions. The European Commission’s table (revision 3, 18 August 2025) is the working reference. • Translation is a pre-CE marking obligation. Notified Bodies check translation completeness as part of technical documentation review under Annexes IX to XI. • Other regulated documents (implant cards, SSCPs, declarations of conformity, field safety notices, EUDAMED labelling data, clinical investigation documents) each sit under their own article and have their own language scope. • Process quality is governed by ISO 17100 for human translation and ISO 18587 for any post-edited machine translation. Both apply in MDR work. • Buyers evaluating a supplier should demand certified processes, EUDAMED-aligned terminology management, an audit trail, and demonstrable Notified Body submission experience. |
What MDR Article 10(11) actually requires
Article 10(11) of Regulation (EU) 2017/745 sits in Chapter II under manufacturer obligations. It requires the manufacturer to ensure that the device is accompanied by the information set out in Annex I Section 23 in the official language(s) of the member state where the device is made available to the user or patient. The obligation applies before the device is placed on the market, and Notified Bodies verify translation completeness during technical documentation review for any device that requires third-party conformity assessment.
The legal anchor: Article 10(11) and Annex I Section 23
Annex I Section 23 defines accompanying information as what is needed to identify the device and the manufacturer, together with safety and performance information relevant to the user. The scope covers three surfaces. Section 23.1 sets the general principles around legibility and comprehensibility to the intended user. The label-specific rules sit in Section 23.2. The IFU-specific rules sit in Section 23.4. Where the manufacturer maintains a website, the same accompanying information must be available there in the same member-state languages.
Why Article 41 is the wrong citation for IFU translation
Some industry shorthand cites Article 41 as the IFU translation obligation. That citation is wrong. Article 41 sits in Chapter IV (Notified Bodies) and governs the language of documents related to the designation of Notified Bodies under Articles 38 and 39. It has nothing to do with the information that accompanies a device. Citing it in supplier RFPs or in internal regulatory documentation creates downstream confusion and signals to a reader who knows the regulation that the author has not checked the article structure. Worth flagging to procurement so the template gets fixed.
| Common citation error Article 41 covers the language of Notified Body designation documents. Article 10(11) plus Annex I Section 23 covers the information accompanying the device. The two sit in different chapters of the regulation and address different obligations. |
Which documents must be translated under MDR
Translation under MDR covers labels and packaging, IFUs, implant cards, summaries of safety and clinical performance for Class III and implantable devices, declarations of conformity, field safety notices, EUDAMED labelling data, and clinical investigation documents. Each document type sits under its own article, with its own language scope. Not every document goes into every market, and not every document needs every language. Pharma sits under a different regulation entirely – Directive 2001/83/EC – and is covered in package leaflet translation.
| Document type | Primary MDR article | Language scope | Notes |
| IFU | Art. 10(11) + Annex I §23 | Per member state | Full translation. No symbol substitution for narrative content. |
| Label and packaging | Art. 10(11) + Annex I §23.2 | Per member state | ISO 15223-1:2021 symbols can substitute for text on many elements. |
| Implant card | Art. 18 | Per member state | Patient-facing. MDCG 2019-8 recommends recognised symbols. |
| SSCP (Class III and implantable) | Art. 32 | Per member state | Made public via EUDAMED. See MDCG 2019-9 Rev.1. |
| Declaration of conformity | Art. 19 | Member state may require translation into accepted EU language(s) | Single EU language often accepted as a baseline. |
| Technical documentation | Annex II + III | Notified Body working language (commonly English) | Authorities may request translated extracts for surveillance. |
| Field safety notice | Art. 89(8) | Per member state of the affected device | Linked to corrective action communications. |
| EUDAMED labelling data | Art. 29 + UDI rules | Varies by data field | Must match physical IFU and label. |
| Vigilance / serious incident reports | Art. 87 | Receiving competent authority’s accepted language | Often national language or English by negotiation. |
| PSUR | Art. 86 | Submitted via EUDAMED | Language follows EUDAMED submission practice. |
| Clinical investigation summary / lay summary | Art. 77 + Annex XV | Per member state for the lay summary | Lay summary must be patient-readable. |
| Custom-made device statement | Art. 52(8) + Annex XIII | Member state of supply | Relevant to dental, orthotic, rehabilitation device manufacturers. |
Patient-facing documents
IFUs and implant cards need full translation, with no symbol shortcut for IFU narrative. Labels can use ISO 15223-1:2021 symbols to substitute for text on a wide range of elements, including sterility status, single-use designation, expiry, lot number, manufacturer identification, and date of manufacture. Most manufacturers use a single multilingual label design across markets rather than a separate label per country.
Some member states still require a textual equivalent alongside specific symbols, so verify with the competent authority before standardising any label design. Lay summaries in clinical investigation results, and the patient-facing sections of SSCPs, have to be written so a non-specialist can understand them.
Regulatory and post-market documents
Technical documentation usually goes to the Notified Body in English as the body’s working language. National authorities can request translated extracts during post-market surveillance, so the underlying technical content should be translation-ready even when full translation is not required up front. SSCPs for Class III and implantable devices must be translated into the official language(s) of every member state where the device is sold, then made public via EUDAMED.
Declarations of conformity, field safety notices, and vigilance reports each follow their own article-specific language scope. Clinical investigation documents fall under Article 77 and Annex XV, with the lay summary translated per member state. For the deeper read on clinical trial document translation across the EU CTR, the UK CTR 2025, and ICH E6(R3), see clinical trial translation. Software classified under MDR Rule 11 – SaMD, embedded software, companion patient apps – brings a distinct artefact set (UI strings, error messages, IEC 62304 documentation, AI Act technical documentation) that sits outside this piece; that scope is covered in medical software translation.
Which languages, in which member states
MDR requires translation into the official language(s) of every member state where the device is sold. The European Commission publishes a consolidated table, currently at revision 3 dated 18 August 2025, with per-country and per-document rules. About half of EU member states require their national language for the IFU. The remainder accept English for professional-use devices under specific conditions. Build your language matrix from the markets you actually sell into, then check the EC table for each market’s current rule.
| Member state | Primary IFU language | Primary label language | English for professional users? |
| Germany | German | German | Limited (non-essential info only) |
| France | French | French | No |
| Italy | Italian | Italian | No |
| Spain | Spanish | Spanish | No |
| Poland | Polish | Polish | No |
| Netherlands | Dutch | Dutch | Conditional |
| Sweden | Swedish | Swedish | Conditional |
| Denmark | Danish | Danish | Conditional |
| Finland | Finnish + Swedish | Finnish + Swedish | Conditional (non-essential info) |
| Belgium | Dutch, French, German | Dutch, French, German | No |
| Romania | Romanian | Romanian | Conditional (updated 2024–2025) |
Excerpt only. The full per-country rule set, including provisions for each document type, is in the European Commission MDR language requirements table (revision 3, 18 August 2025). Verify each of your markets against the current revision before finalising any language matrix.
The 24-language myth
The EU has 24 official languages. Manufacturers translate only into the languages required by the markets they actually sell into. A manufacturer selling exclusively in Germany, France, and Spain needs German, French, and Spanish. Full 24-language coverage applies only to a manufacturer covering every member state. Some member states have more than one official language. Belgium covers Dutch, French, and German. Luxembourg covers French, German, and Luxembourgish. Malta covers Maltese and English. Multi-language member states add lines to the matrix, but the matrix itself is built from the distribution map, not from a blanket EU-wide rule.
| Myth: all EU devices need 24-language translation The translation scope follows the markets you sell into, not the membership list of the EU. Build the language matrix from your distribution map. Verify each market against the current EC table. |
English acceptance for professional users
English IFUs are accepted in a subset of member states under specific conditions. The usual conditions: the device is for professional use only, no lay user contact, the label still requires the national language, and in some markets a national-language summary alongside the English IFU. Romania updated its conditions during 2024 and 2025, which means manufacturers working from pre-2024 language matrices have at least one outdated line in their planning.
Lock the EC table revision into the language matrix as a controlled document with a version number and a date of last verification. Review every six months at minimum, more frequently for markets that have updated their conditions recently. Pair this with your terminology management workflow so that translation memories and the language matrix stay in sync.
How device risk class changes the translation scope and timing
All MDR-regulated devices, from self-declared Class I through Class III implantable, fall under the Article 10(11) translation obligation. What changes by class is the additional regulated content that must be translation-ready before market entry, and the lead time the manufacturer needs before Notified Body submission.
| Risk class | Notified Body involvement | Mandatory translated documents | Translation lead time* |
| Class I (non-sterile, non-measuring, non-reusable) | Self-declared | IFU, label, packaging | 4–6 weeks |
| Class I sterile / measuring / reusable | NB for the relevant aspect | Same plus aspect-specific documentation | 6–8 weeks |
| Class IIa | Full NB conformity assessment | IFU, label, packaging, declaration of conformity, technical doc extracts on request | 8–10 weeks |
| Class IIb | Full NB conformity assessment | Same as IIa, plus additional clinical data extracts | 8–10 weeks |
| Class III | NB conformity assessment with scrutiny | Same as IIb, plus SSCP | 10–12 weeks |
| Implantable | Full NB conformity assessment | Same as Class III, plus implant card | 10–12 weeks |
| Custom-made | Article 52(8) route | Annex XIII statement, IFU, label | 4–6 weeks |
*Lead-time figures assume translation into a 6 to 8 language matrix with a documented QA cycle. Your supplier should be able to give you their own figures for your specific scope.
Class I, implantables, and custom-made: the edge cases
Class I non-sterile, non-measuring, non-reusable devices are self-declared by the manufacturer with no Notified Body involvement. Article 10(11) still applies. The IFU and label still need translation into the languages of every member state where the device is sold. This is the easiest category to under-resource, because the absence of Notified Body pressure removes the external trigger that forces a structured submission timeline.
Implantable devices require a separate implant card under Article 18 in addition to the IFU. The implant card is patient-facing, and is best treated as its own translation workstream. Custom-made devices follow the Article 52(8) route and require an Annex XIII statement in the language(s) of the member state of supply. This bites for dental, orthotic, and rehabilitation device manufacturers, and the scope is often missed in supplier RFPs.
For the deeper read on QA methods that apply across these categories, including ISO 17100 process, ISO 18587 for post-edited machine translation, back-translation, and in-country review, see the cluster piece on medical translation quality assurance.
EUDAMED data alignment: why translation accuracy is now auditable
EUDAMED, the European Database on Medical Devices, requires labelling data to match what appears on the physical device and in the IFU. Translation discrepancies between IFU, label, and EUDAMED entries are a non-conformity trigger. The first four EUDAMED modules become mandatory for new devices on 28 May 2026, with legacy devices following on 28 November 2026.
The four modules are actor registration, UDI and devices registration, Notified Bodies and certificates, and market surveillance. Where intended-purpose statements, device descriptions, or risk-class information appear in EUDAMED and also in the IFU, all sources must agree. Terminology aligned to the European Medical Device Nomenclature (EMDN) is the operational anchor.
MDCG 2021-26, the Commission guidance on repackaging and relabelling activities, says in Q13 that the translated IFU should always be an exact translation of the original version provided by the manufacturer. That is the regulatory backing for refusing in-market improvements to translated text. If a country-based reviewer wants to adapt the IFU during localisation, the source has to be amended by the manufacturer first, with the change reflected in EUDAMED, and the translation updated to follow.
A worked example. A MedTech manufacturer enters an intended-purpose statement into EUDAMED in English. During localisation, the translated IFU expands the same statement to read more naturally in German. A market surveillance review flags the inconsistency between the two records. This kind of failure is avoidable with a locked termbase before translation begins, terminology management carried into every language, and a pre-submission alignment check between EUDAMED entries and the translated content. SmartDesk carries that audit record as a project deliverable.
MDR translation vendor evaluation checklist
An MDR-ready translation supplier holds the right certifications, has Notified Body submission experience, offers EMDN-aligned terminology management, supports in-country reviewers in final layout, and produces a per-project audit trail. The checklist below lifts directly into a supplier RFP.
| Criterion | Why it matters under MDR | What to ask in the RFP |
| ISO 17100 | Process foundation for human translation | Please attach your current ISO 17100 certificate and certification body. |
| ISO 18587 | Required when MTPE is used | Do you hold ISO 18587 for any post-edited MT workflows? Please attach the certificate. |
| ISO 13485 awareness | Quality management for medical devices | Describe how your QMS aligns with ISO 13485 expectations even if you do not hold the certification. |
| ISO 27001 | Information security for regulated content | Please confirm ISO 27001 certification and attach evidence. |
| Notified Body submission experience | Operational fluency on real submissions | Provide three examples of MDR submissions where your translations went through Notified Body review without remediation. |
| EMDN-aligned terminology management | EUDAMED data consistency | Describe how your termbase is built, locked, and aligned to EMDN nomenclature. |
| Audit-trail capability | Evidence for Notified Body and surveillance review | What per-project audit records do you produce, and for how long do you retain them? |
| In-country reviewer support | Supports member-state RA leads | How do in-country reviewers access translated IFUs for review? Do they need third-party software licences? |
| In-layout review | Removes DTP/InDesign friction for label and IFU artwork | Can in-country reviewers edit translated content in final layout via your platform? |
| Surge capacity | Multi-market parallel submissions | Describe how you handle a 6-language MDR submission with a 4-week window. |
AdHoc holds current ISO 17100 and ISO 18587 certifications. Both certificates are on our site for buyers to verify directly. SmartDesk carries the per-project audit trail and project visibility that Notified Bodies expect to see during technical documentation review.
SmartEdit lets in-country reviewers edit translated IFUs and labels in final layout without an InDesign licence, which removes the licensing friction that slows multi-market submission cycles. MedTech promotional and educational content directed at healthcare professionals – sales aids, KOL slide decks, congress materials under the MedTech Europe Code of Ethical Business Practice – sits outside MDR conformity and is covered in HCP content translation. For the deeper read on the QA stack across all medical translation work, see medical translation quality assurance.
Frequently asked questions
What is MDR Article 10(11)?
Article 10(11) of Regulation (EU) 2017/745 is the manufacturer obligation that requires every medical device to be accompanied by the information set out in Annex I Section 23, including labels, packaging, and IFUs, in the official language(s) of the EU member state where the device is made available. It is the primary translation obligation under the MDR.
Do medical device IFUs need to be translated into all 24 EU languages?
No. Manufacturers only need to translate IFUs into the official language(s) of the member states where the device is sold. A manufacturer selling exclusively in Germany, France, and Spain needs German, French, and Spanish, not all 24 EU languages. The European Commission’s table sets the per-country rule and is the working reference.
Is English ever accepted under MDR?
Yes, under specific conditions, in specific member states, for specific user groups. The Netherlands, Sweden, Denmark, and a handful of others accept English IFUs where the intended user is a healthcare professional. Conditions vary and were updated during 2024 and 2025. The European Commission’s table is the authoritative source.
Does the MDR apply to UK manufacturers selling into the EU?
Yes. UK manufacturers placing medical devices on the EU market must comply with the MDR, including translation requirements. The MDR does not apply in Great Britain, where the UK MDR 2002 still governs and the MHRA oversees compliance. The MDR continues to apply in Northern Ireland under the Windsor Framework.
Speak with our localisation team
If your current translation supplier cannot answer the checklist questions with documented evidence, a structured supplier review is the next step. Speak with our localisation team about how AdHoc handles MDR translation work for MedTech manufacturers across the EU.
Sources
- EUR-Lex, Regulation (EU) 2017/745 of 5 April 2017 on medical devices. https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng. Accessed 14 May 2026.
- European Commission, Overview of language requirements for manufacturers of medical devices (MDR table, revision 3, 18 August 2025). https://health.ec.europa.eu/publications/overview-language-requirements-manufacturers-medical-devices_en. Accessed 14 May 2026.
- European Commission, EUDAMED overview. https://health.ec.europa.eu/medical-devices-eudamed/overview_en. Accessed 14 May 2026.
- MDCG 2021-26, Q&A on health institution exemption from regulatory requirements for in-house developed devices, and repackaging and relabelling activities (October 2021), Q13.
- MDCG 2019-9 Rev.1, Summary of safety and clinical performance — A guide for manufacturers and notified bodies.
- ISO 17100:2015, Translation services — Requirements for translation services.
- ISO 18587:2017, Translation services — Post-editing of machine translation output — Requirements.
- ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the manufacturer.