Scope EU medical-device language work by country, intended user and document type: labels, IFUs, declarations, technical documentation and revision control.
View the file review example ↓View references (3) ↓Language is set per member state
For information accompanying a device, MDR Article 10(11) and IVDR Article 10(10) refer to official Union languages determined by the relevant Member State. The required set depends on the market, document and intended user, including professional-use provisions where applicable.
Use the Commission’s country tables as a starting point, then verify the current national position. Notified-body documentation languages and customer-facing labels or IFUs are separate questions; not every device requires a notified-body assessment.
Define the document scope before counting languages
Record the requirement and approval owner for each category. Technical-documentation language is not automatically the same as the IFU language set.
| Document | What to verify |
|---|---|
| Labels and IFU | Member State provisions, intended user and applicable exceptions. |
| Declaration of conformity | Languages required where the device is made available. |
| Technical documentation | Authority or assessment-route requirements and, where applicable, languages accepted by the notified body. |
| GUI and revision notices | Applicable national rules and consistency with the controlled document set. |
Freeze the market list and source revision together
Give each file a document ID and source revision. For each market, record the intended user, document category, required language and the person who confirms that requirement. List editable source files, figures and appendices so that the quotation covers the same set the reviewers will receive.
A China-based team may also need a Chinese reference copy for internal review. Brief that as a separate output from the EU market-language versions, tied to the same source revision. State who will review it and how comments return to the source owner. It does not replace the required EU versions or determine the documents needed for a Chinese filing.
From reading to a project
Keep EU versions and Chinese reference files distinct
Document-language register · self-created
- Controlled source
- DEMO-DOC-07 · source revision C · list figures and appendices
- EU market-language set
- Record actual market, intended user, document category, language and regulatory decision owner
- Chinese internal reference
- DEMO-DOC-07-CN：C版源文对应的中文内部审阅稿；与欧盟市场发布文件分别登记
- Question and return record
- DEMO-Q1 · source location, answer owner, reviewed return-file revision and open items
Review status: questions to confirm
Confirm the actual EU scope
Name the markets, intended users and document categories. Ask the regulatory owner to confirm the applicable language requirements.
Separate the Chinese review copy
If China-based colleagues need a reference copy, identify its script, review owner and purpose separately from the EU release files.
Return a traceable revision set
Agree the source baseline, changed passages, question log and file list. Keep internal review copies identifiable at handover.
Related published experience
Jiangsu Xinlikang MedicalGerman → Chinese / English
Technical documentation for imported medical devices.
The Jiangsu Xinlikang case records German-to-Chinese and English technical documentation for imported medical devices. It does not identify an MDR/IVDR market-language set, a specific label or IFU, or regulatory approval. The register above is an invented preparation example.
Tell us whether the project covers EU market-language files, a Chinese internal reference copy, or both. Include source languages, actual files and revisions, markets, intended readers, required return formats, review owners and deadline. Confirm applicable regulatory requirements with the responsible owner.
Revisions are the real test
When a source passage changes, send the new source revision with a marked comparison or change list where available. Identify the affected language files and agree the review scope before updating them. A paragraph change may also affect a figure, screen label or cross-reference.
Keep the return-file register with the revision package. Record which files were updated, who reviewed them and any questions still open. If a Chinese internal reference copy is included, identify it separately so it is not confused with an EU market release.
| Record | Reviewer action |
|---|---|
| Changed source passage | Identify the document revision and affected language files; agree whether surrounding text also needs review. |
| Terminology decision | Link the question and agreed wording to the source location and decision owner. |
| Released return set | List the returned file versions, intended markets and unresolved items before handover. |
Have the responsible regulatory owner confirm each market requirement. Where a notified body is involved, confirm its accepted documentation languages separately.
Questions
How many languages will we actually need?
Does the technical file need translating too?
Can you handle all required languages?
Can the same source also support a Chinese internal review copy?
Sources
- Regulation (EU) 2017/745 — Medical Device RegulationArticles 10(11), 19(1), 52(12) and Annex I section 23 address different documentation and language questions; use the current consolidated text linked by EUR-Lex.
- Regulation (EU) 2017/746 — In Vitro Diagnostic Medical DevicesArticle 10(10) addresses information accompanying the device. Check the current consolidated text and national requirements.
- European Commission — language requirements for device manufacturersCountry tables are a starting point; check the table revision, document category, intended user and national provisions.