EU MDR Technical File Translation: What Notified Bodies Expect
Translating MDR technical documentation for notified-body review—definitions, residual risk language, CER linkage and bilingual Q&A packs that reduce clarification loops.
Why wording matters in MDR files
Notified bodies scrutinize intended use, classification rationale and residual-risk statements. Literal translation can blur defined terms and create unnecessary deficiency questions.
High-impact chapters
- Device description and intended purpose
- Clinical evaluation and PMCF summaries
- Risk management excerpts tied to labeling
- Declarations and label/IFU consistency tables
Delivery tips
- Freeze source revision and annex list before kickoff
- Lock a medical glossary for defined MDR terms
- Provide bilingual packs for NB Q&A rounds
See our MDR translation service.
Share this article
