Record applicable language requirements, document scope, source versions, change triggers and decision owners for each target market.
View references (3) ↓- Why we are not publishing a dated list
- What each entry needs
- Tie it to your own change events
- Keep the requirement and its evidence together
Why we are not publishing a dated list
Language obligations and their deadlines change, and they differ by product class, pathway and market. A dated table published here would be wrong for some readers on the day it went up and wrong for everyone eventually.
Build the calendar with your regulatory or product-compliance owner. Use the relevant authority’s current rules and, where applicable, the notified body’s assessment requirements. A general checklist is a verification prompt, not a determination for your product.
What each entry needs
For every market and product class: which documents must be in the local language, which languages count as acceptable, what triggers a re-translation obligation, and who verified it and when.
That last field is the one teams omit and the one that matters most. A requirement with no verification date is indistinguishable from a guess after a year.
The China project source and open-requirement registers provide printable fields for official URLs, version dates, applicability and the decision owner.
Tie it to your own change events
Most language obligations are triggered by your actions rather than by a date: entering a market, changing labelling, revising an IFU, adding a variant. Build the calendar around those events and the review cadence follows naturally.
Then set a fixed re-verification interval — at a risk-based interval set by the regulatory owner, and recheck before a relevant launch or change. An annual review can be a planning baseline, not a universal legal rule.
Keep the requirement and its evidence together
Record the official URL, publication or revision date, applicable product and document, accepted language, trigger or deadline, reviewer and unresolved points. The Commission’s device-language tables, FDA’s eSTAR page and EUR-Lex machinery text illustrate different kinds of source; none covers every market or product.
| Field | What belongs in it |
|---|---|
| Applicability | Market, product class, pathway and document category. |
| Source | Official URL, version and verification date. |
| Action | Trigger or deadline, owner, evidence and open questions. |
Questions
Can you tell us what our markets require?
How often should the calendar be reviewed?
What is the most common gap?
Sources
- European Commission — language requirements for device manufacturersCountry tables are a starting point; check the table revision, document category, intended user and national provisions.
- FDA — eSTAR ProgramCurrent submission and technical-screening guidance; exceptions and submission-center instructions matter.
- Regulation (EU) 2023/1230 — Machinery RegulationArticles 51–54: main application and repeal date 20 January 2027, with earlier provisions and transitional rules.