EU MDR Translation Checklist for Technical Documentation

Modules that commonly need language versions

• Device description and manufacturing summaries
• ISO 14971 residual-risk language
• CER / PMCF excerpts
• IFU, labels and patient cards

Pre-kickoff checklist

1. Confirm member-state languages
2. Freeze source revision with NB language strategy
3. Build MDR glossary and do-not-translate IDs
4. Plan DTP for symbols and A4 templates