Separate submission, labelling and IFU language scope for FDA and EU device projects. Questions and official sources for a translation brief.
Online brief · no downloadable report · Updated 2026-10-11
Submission documents, labelling and instructions for use do not share one universal language rule. This brief covers FDA and EU source references only; it is not a complete NMPA, PMDA or GCC checklist. The manufacturer and regulatory owner should confirm the product, document set, destination and assessment route before translation starts.
Confirm whether the 510(k) uses eSTAR, which supporting files need English versions and who controls the source record. eSTAR technical screening and traditional refuse-to-accept procedures should not be treated as the same check. Translation completion is not FDA clearance.
MDR Article 10(11) and IVDR Article 10(10) address information supplied with devices in languages determined by Member States. Technical documentation and declarations have their own provisions; professional-use exceptions vary and must not be assumed.
Record the approved source version, target-market language list and release owner. Ask for terminology and cross-reference checks appropriate to the agreed review level; do not present a translated IFU as a compliance certificate.
Read the current scope and applicable provisions in the issuing body's source. These references do not certify a project or replace product-specific review.