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Accurate Translations for EU MDR-Compliant Clinical Evaluation Reports
Clinical Evaluation Reports (CERs) are a core requirement under the EU Medical Device Regulation (EU MDR 2017/745) for obtaining and maintaining CE marking. These technical documents must demonstrate clinical safety and performance, often requiring submission in the language of the reviewing Notified Body or national authority. Inaccurate or non-compliant translations can result in regulatory delays, rejections, or costly rework.
Sesen provides expert CER translation services tailored to the needs of global medical device manufacturers. Our linguists combine medical subject matter expertise with in-depth knowledge of MDR requirements to deliver precise, regulator-ready translations that support timely market entry and post-market compliance.
What Is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a regulatory document required under EU MDR Annex XIV, Part A that demonstrates the clinical safety, performance, and overall benefit of a medical device throughout its lifecycle. CERs are essential for obtaining and renewing CE marking in the European Union and are subject to detailed review by Notified Bodies.
A well-structured CER typically includes:
- Clinical data analysis from clinical investigations, published studies, and post-market data
- Literature review demonstrating conformity with General Safety and Performance Requirements (GSPRs)
- Equivalence analysis comparing the device with similar CE-marked alternatives
- Risk-benefit assessment to confirm favorable therapeutic outcomes under intended use
- Post-market surveillance (PMS) integration, including complaint trends and vigilance data
CERs must be regularly updated and translated when submitted to national authorities or non-English-speaking Notified Bodies. Accurate, context-sensitive translation is essential to avoid misinterpretation and ensure regulatory compliance.
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Why CER Translation Matters for Global Market Access
Accurate translation of Clinical Evaluation Reports (CERs) is essential for regulatory success in the European Union and other multilingual markets. While English is commonly used, many EU Notified Bodies and local Competent Authorities require CERs to be submitted in their official language, particularly for Class IIb and III devices or national-level reviews.
Multilingual CERs are also critical for:
- In-country regulatory reviewers who assess documentation for conformity with EU MDR (2017/745)
- Local Competent Authorities in decentralized approval settings
- International QA/RA teams involved in collaborative regulatory workflows
Translation errors can lead to regulatory delays, misinterpretation of clinical claims, and additional scrutiny or rejection by Notified Bodies. Sesen ensures that every CER translation maintains the original document’s technical accuracy, regulatory integrity, and clinical relevance, supporting faster CE marking and uninterrupted market access.
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Sesen’s Specialized CER Translation Process
At Sesen, we follow a structured, regulatory-aligned process to ensure every Clinical Evaluation Report translation meets the highest standards for accuracy, compliance, and regulatory readiness. Our workflow is designed specifically for medical device manufacturers operating under EU MDR, MEDDEV 2.7/1 Rev. 4, and ISO 14155 frameworks.
Linguistic Team with Regulatory Expertise
We assign certified medical translators with deep knowledge of MDR clinical evaluation requirements, device classifications, and safety-performance benchmarks. Our linguists have hands-on experience translating:
- Class IIb and III CERs
- Clinical literature reviews
- Equivalence justifications and PMS data They are trained to recognize critical regulatory phrasing and maintain consistency with terminology accepted by Notified Bodies.
Source Document Assessment & Scope Definition
Each CER is first reviewed by our project managers and regulatory linguists to:
- Evaluate document structure, formatting style, and reference material
- Identify complex sections including clinical data, risk-benefit summaries, and bibliographies
- Define turnaround times based on document length, device risk class, and language requirements
Term Consistency with IFUs, Risk Files, and Technical Documentation
We ensure terminology is harmonized across all related documents to support regulatory alignment:
- Reference previously submitted Instructions for Use (IFUs), risk management files, and technical documentation
- Apply client-approved glossaries, style guides, and controlled terminology databases for consistency and accuracy
Back Translation and In-Country Review (Optional)
For high-risk devices or upon request by Notified Bodies, we offer:
- Back translation and comparative reconciliation to verify semantic fidelity
- Collaboration with local regulatory experts or reviewers to confirm accuracy in context and meet country-specific expectations
Final QA with Regulatory Formatting
Our final step includes:
- Thorough linguistic QA and proofreading by a second linguist
- Formatting review to ensure proper structure, citations, and section headings aligned with MDR templates
- Optional bilingual layout formatting for client-side review and submission packages
Supported Languages & Markets
Sesen provides Clinical Evaluation Report translation services in over 150 languages, helping medical device manufacturers meet regional language requirements for regulatory submissions. Our expert linguists translate CERs with precision and compliance for markets across the EU, Asia-Pacific, and beyond.
We support high-demand languages including:
German, French, Spanish, Italian, Dutch, Swedish, Polish, Chinese, Japanese, Korean, and Portuguese, among others.
Regional Regulatory Experience
Our CER translation expertise extends across key regulatory agencies and Notified Bodies, including:
- TÜV SÜD, BSI, GMED, DEKRA – Leading EU Notified Bodies requiring language-specific CER submissions
- NMPA (China), MFDS (Korea), PMDA (Japan) – Regional authorities with local language mandates and format preferences
Sesen's global linguistic reach and deep familiarity with regional MDR submission protocols make us a trusted partner for multilingual CER translation across regulated markets.
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Integration with Broader Regulatory Documentation
Clinical Evaluation Reports (CERs) are not standalone documents; they form a critical component of a medical device’s overall regulatory submission package. At Sesen, we provide integrated translation services that align CERs with supporting documentation to ensure consistency, traceability, and full MDR compliance.
Our CER translation services connect seamlessly with:
- IFU & Technical Documentation Translation Alignment with device descriptions, intended use, warnings, and clinical performance claims across all user-facing and regulatory materials.
- Risk Management File Translation (ISO 14971) Harmonized terminology for risk-benefit assessments and hazard analyses, ensuring coherence between clinical evidence and documented risk controls.
- Post-Market Clinical Follow-up (PMCF) Translation Integration of ongoing clinical data and surveillance findings into CER updates, supporting lifecycle compliance under MDR Article 61 and Annex XIV.
- UDI & EUDAMED Submissions Consistent device identification and structured data field translations for regulatory databases, minimizing discrepancies and enhancing traceability.
With deep expertise across the entire regulatory content spectrum, Sesen delivers complete multilingual support for medical device submissions. All translated components are aligned with your clinical evaluation strategy to meet international compliance standards.
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Quality, Confidentiality, and Compliance Standards
At Sesen, we apply rigorous quality and data protection protocols to every Clinical Evaluation Report (CER) translation project, ensuring regulatory compliance, linguistic precision, and the highest level of confidentiality.
ISO 17100-Certified Translation Quality
All CER translations are performed and reviewed by qualified medical linguists in accordance with ISO 17100 standards, ensuring terminology accuracy, reviewer independence, and documented quality control procedures.
ISO 13485 Alignment with Medical Device QMS
Our processes are fully aligned with ISO 13485 requirements, supporting manufacturers’ Quality Management Systems for medical device design, production, and regulatory documentation.
Secure Platforms and Strict NDA Enforcement
We use encrypted platforms for file transfer and project management, with enforceable non-disclosure agreements to protect proprietary clinical data and regulatory materials.
Version Control, Change Tracking, and Audit Readiness
All deliverables are tracked with version control and revision logs to support traceability, internal audits, and Notified Body reviews. Clients receive full visibility into translation workflows for compliance documentation.
Sesen’s commitment to quality and security ensures that your CER translations meet both linguistic and regulatory expectations across global markets
Use Cases & Success Stories
Multilingual CER translation for Class III cardiovascular implant
Delivered fully compliant CER translations in German and French for a European Class III implantable device, enabling a smooth CE marking process through TÜV SÜD and accelerating time to market.
Rapid CER update for diagnostics manufacturer under Notified Body deadline
Provided expedited translation of updated post-market clinical data for a leading IVD company. The translated CER was submitted within 72 hours to meet a Notified Body’s urgent review timeline.
Integrated translation for global orthopedic device launch
Successfully translated and harmonized the CER, IFU, and risk management documentation for a multinational orthopedic manufacturer, ensuring regulatory consistency across EU, APAC, and LATAM markets.
These examples reflect Sesen’s ability to support complex, high-risk medical device submissions with accuracy, speed, and deep regulatory insight.
Frequently Asked Questions
Do you work with native-speaking medical translators?
Yes. All CER translations are performed by professional native-speaking medical translators with expertise in EU MDR, MEDDEV 2.7/1 Rev. 4, and ISO 14155 standards. Our linguists are trained to handle complex clinical and regulatory content with precision.
Can you translate large CERs with tight regulatory deadlines?
Absolutely. Sesen supports high-volume CER translations under accelerated timelines, including urgent Notified Body resubmissions and post-market surveillance updates. We allocate scalable linguistic teams and dedicated project managers to meet your regulatory deadlines without compromising quality.
Do you offer back translation and reconciliation services?
Yes. For high-risk devices or upon request, we offer back translation with reconciliation, reviewed by independent linguists or in-country experts. This service helps validate translation accuracy and meet specific Notified Body requirements for clinical data transparency.
How do you ensure regulatory compliance in translations?
Our translation workflows are aligned with ISO 17100 and ISO 13485 standards. We implement quality checks at every stage, maintain consistency with IFUs and risk files, and use approved glossaries and templates to meet regulatory expectations for CER submissions.
Can you work with XML or preformatted CER templates?
Yes. Sesen works with various structured formats, including XML, DOCX, and client-specific CER templates. We preserve section headings, references, and formatting rules to support seamless integration into your submission-ready files or document management systems.