EU IVDR Compliance Services for Medical Device Market Access
Achieve Seamless EU Market Approval with Expert IVDR Translation and Certified Compliance Documentation
What Is IVDR? Why Does It Matter?
The In Vitro Diagnostic Regulation (IVDR) has replaced the former IVDD, introducing stricter standards for the safety and performance of diagnostic devices across the EU. By May 2025, all manufacturers must transition from IVDD certificates to the new IVDR framework, which classifies devices under a risk-based system (Class A–D). This shift requires meticulous accuracy in both technical documentation and translation—where even the smallest error can result in costly delays, regulatory non-compliance, or rejected market applications.
Navigate Your IVDR Transition with Confidence
Our specialized IVDR compliance services provide the accurate, certified translations you need for technical documentation, ensuring full adherence to Annex I requirements and a successful transition to the new regulatory framework.
IVDR Compliance Support
Our end-to-end solution ensures your technical documentation meets all linguistic requirements of Regulation (EU) 2017/746. Multilingual Coverage: Expert translation into all 24 official EU languages by in-country linguists.
- Terminology Consistency: Rigorous management of medical and regulatory terminology across all documents.
- Regulatory QA: Dedicated quality assurance checks by specialists familiar with IVDR structure and requirements.
- Dynamic Updates: Continuous support for updating documents as regulations and standards evolve.
Strengths
Why Choose EC Innovations for IVDR Translation
EC Innovations vs. Typical Localization Providers
| Comparison Criteria | EC Innovations Advantages | Typical Provider Limitations |
|---|---|---|
| Regulatory & Medical Expertise | ✅ Subject-matter expert translators with deep familiarity of IVDR-specific terminology and requirements. ✅ Dual-certified linguists with 10+ years of experience in medical device translation. | ❌ Use general translators without medical or regulatory background. ❌ Lack specialized knowledge in IVDR documentation. |
| Quality & Certification | ✅ ISO 17100 and ISO 13485 certifications for rigorous quality and medical device compliance. ✅ Robust quality assurance (QA) processes include regulatory compliance checks. | ❌ Quality processes are not tailored to medical device standards. ❌ QA focuses only on linguistic accuracy, not regulatory alignment. |
| Terminology & Consistency | ✅ Centralized terminology management ensures consistency across all IVDR technical files. ✅ Secure glossary development specific to your device and IVDR classification. | ❌ Inconsistent term usage leads to documentation errors. ❌ Lack of tools for managing complex medical terminology. |
Subject Matter Experts and Translation Teams in IVDR Compliance
Dual-certified linguists with 10+ years IVDR experience deliver precise medical device translations compliant with Annex I requirements and EU regulations for seamless market approval
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Subject-matter experts (SMEs)
With appropriate industry backgrounds,meet SMEs with extensive experience of document translation. They support terminology translation and maintenance while answering any technical questions translators may have.
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Qualified translators
All our translators receive thoroughgoing assessment based on our Translation Quality Report (TQR). We also take the trouble to match translators to particular clients and product lines, to see that their knowledge of your business – and hence their utility on your projects – is always growing.
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Experienced editors
With years of experience in document translation, EC Innovations’ editors use our cloud-based Computer-assisted Translation tool to review and make edits in real time. Generating feedback and approvals in the shortest possible time-frame.
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Exacting proofreaders
Background knowledge in the relevant field allows our proofreaders to play the part of end users. They always review translations with a fresh eye, and without reference to source content.
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Quality assurance reviewer
Our QA team samples 10% to 20% of total translations. Clients get independent verification of quality – and immediate identification of any issues.
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In-country reviewers or third-party reviewers
Always available on request to serve as further guarantors of translation quality.
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In-country language leaders
These key individuals work closely with translator recruitment and management to build dedicated teams of translators for each client.
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Multilingual desktop publishing team
Readying translated documents for publication in the correct format, to ensure compliance.
CERTIFICATION
ISO Certified
We are one of the few language service providers in the world that holds ISO 9001, ISO 17100, ISO 27001, and ISO 14001 certifications.
We attach a high degree of importance to the delivery and quality assurance process of translation services. For EC Innovations, providing quality services has always been the guiding force behind our corporate values and beliefs. We do this by implementing rigorous and comprehensive quality assurance procedures, following comprehensive guidelines and checklists embedded throughout the entire project lifecycle. Tasks with substandard results will be reworked until the required quality level is achieved.
ISO 9001
ISO 17100
ISO 27001
ISO 14001
INSIGHTS
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Get in touch
Ensure your IVDR documentation is accurately translated and fully compliant. Contact our regulatory translation experts today for a confidential consultation and a free quote.
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