Medical device manufacturers and IVD companies are under growing pressure to meet the stringent requirements of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). While clinical data, technical documentation, and risk management files take central part, one critical component is often underestimated: accurate and compliant translation.
Even a single linguistic error can lead to approval delays, non-compliance during audits, or even market withdrawals. Here’s how to avoid these high-stakes setbacks:
Common Translation Pitfalls That Cause Delays
- Non-compliance with EU language requirements
MDR/IVDR mandates that documentation be translated into the official language(s) of each country where the product is marketed. Missing or partially translated content is a red flag during conformity assessments. - Unqualified or inexperienced translators
General translators — or AI tools without life sciences expertise — can miss regulatory nuances and even produce hallucinations: misleading content that doesn’t exist in the source text. Literal translations of terms like “intended purpose” or “contraindications” can distort meaning, while AI-generated hallucinations can introduce entirely new errors — both of which can cause serious regulatory errors. - Lack of harmonized terminology
Inconsistent use of terms (e.g., using both “device” and “equipment” for the same product) can confuse users, clinicians, and notified bodies. Harmonization with MedDRA, EDQM Standard Terms, EUDAMED terminology, and EMA-approved glossaries is essential to maintain consistency across technical documentation, regulatory submissions, and user-facing materials. - Poor version control
Using outdated source files or skipping linguistic updates in revisions of IFUs, SSCPs, or DoCs leads to discrepancies that can trigger corrective actions during audits.
Best Practices to Stay MDR/IVDR-Compliant
1. Partner with a specialized medical translation provider
Choose a language service provider (LSP) with ISO 17100 (translation service requirements), ISO 9001 (quality management), and ideally ISO 13485 (medical device quality management) certification. These standards ensure your provider has documented auditable processes for quality, traceability, and risk management — all of which align with MDR/IVDR expectations. Look for proven experience in medical device content and a strong QA process tailored to regulatory requirements.
2. Ensure regulatory alignment
Ask your provider if their translations also follow the latest MDCG guidance, are in line with EMA Q&A terminology, and consider nuances such as country-specific healthcare systems.
3. Build multilingual glossaries & style guides
Establish standardized terminology from the start, using authoritative regulatory sources such as MedDRA, EDQM Standard Terms, EUDAMED terminology, and EMA-approved glossaries. Ensure translators and reviewers are aligned on preferred phrasing, abbreviations, and country name conventions. This avoids costly inconsistencies across IFUs, labels, technical documentation, and regulatory database entries — and helps ensure your product data matches exactly with EUDAMED and national submission requirements.
4. Implement a robust review workflow
Adopt a multi-step linguistic review process: translation → 2-STEP Review process → In-country review check → final QA check. For high-risk devices, consider adding a native-speaking clinician or in-country regulatory expert.
5. Don’t underestimate readability
IFUs and patient leaflets must be clear, especially for lay users. MDR/IVDR require that patient-facing documents are comprehensible to the intended population. Consider readability testing and usability testing.
MDR/IVDR Compliance Is Not Just a Regulatory Checkbox
Language accuracy is part of your risk management strategy. It’s not just about avoiding fines—it’s about protecting patients, users, and your brand.
Need support with MDR/IVDR-compliant translations?
At NN Translations, we specialize in regulatory translations for medical devices and IVDs—backed by ISO certification, native medical linguists, and workflows designed to meet MDR/IVDR standards.
-IFUs
-SSCPs
-DoCs
-Risk Management Files
-Labels & Packaging
-PMS and PSUR reports
-Multilingual glossaries, etc.
Email us at info@nntranslations.com or visit www.nntranslations.com to learn more.
Stay tuned for our next issue
Regulatory References (MDR/IVDR Language & Readability)
- MDCG 2019-9 Rev.1 — Summary of safety and clinical performance (SSCP) for medical devices
- MDCG 2021-24 — Guidance on classification of medical devices
- MDCG 2022-12 — Guidance on harmonised administrative practices & alternative technical solutions until EUDAMED is fully functional
- Guidance – MDCG endorsed documents and other guidance
