Medical Industry Translation Compliance Under EU AI Act

The EU Artificial Intelligence Act 

This article explores five critical challenges facing medical organizations under the EU AI Act and demonstrates how SimulTrans' ISO-certified translation and review services ensure compliance.

The European Union AI Act establishes a comprehensive regulatory framework for artificial intelligence within the EU, ensuring that AI systems are safe, trustworthy, and aligned with fundamental rights. Article 50 of the EU AI Act introduces stringent transparency obligations for AI-generated content, including images, audio, video, and text.  Specifically for text (such as AI-generated translations), this act fundamentally changes how companies can publish raw machine translation.

This means that AI-generated translated content must include machine-readable markers and meet specific disclosure requirements, unless the translations have undergone a human review (post-editing) before publication.

Five Critical Translation Challenges Under the EU AI Act

1. Transparency Requirements for AI-Generated Medical Translations 

Article 50 of the EU AI Act mandates that deployers of AI systems generating or manipulating content must disclose their artificial origin. According to the European AI Office, this disclosure requirement applies unless the content has undergone human review under a responsible entity's oversight. For medical device instructions for use (IFUs), pharmaceutical labeling, clinical trial materials, and patient information leaflets, this creates a critical compliance requirement.

The Challenge

Medical companies using machine translation AI engines for regulatory documents must now either clearly label content as AI-generated or demonstrate comprehensive human oversight. Poorly translated medical documentation can lead to misinterpretation of safety information or incorrect translation of warnings and contraindications, and therefore, increase the legal exposure for companies.

The Solution

SimulTrans' ISO 18587-certified post-editing process ensures that all AI-generated translations undergo rigorous human review by qualified linguists. Our documented quality assurance workflows satisfy Article 50's human oversight requirements, eliminating the need for AI disclosure labels. Every AI output is reviewed, refined, and validated by professional linguists following structured processes that create audit-ready documentation supporting the EU AI Act's compliance obligations.

2. Risk Management Through Human Review of AI Translations

The EU Medical Device Regulation (MDR) mentions that distributors and importers shall ensure that they have in place a quality management system that includes procedures that ensure that the translation of information is accurate and up-to-date.  When combined with the EU AI Act's transparency obligations, medical device companies face complex compliance requirements. 

The Challenge

Medical device manufacturers that are considering AI-translation for any type of documentation, such as IFUs, labels, or risk analyses, must ensure both linguistic accuracy and now regulatory compliance. This is because the EU AI Act adds another layer: companies must document their quality assurance processes and demonstrate that AI-generated translated content has been appropriately reviewed by a human. Without proper documentation, companies risk regulatory delays, product recalls, and significant financial penalties.

The Solution

SimulTrans provides comprehensive risk mitigation through ISO 17100 and ISO 18587 certifications. Our qualified linguists follow rigorous processes for every project, including independent linguistic reviews, back translation verification when required, and certificates of translation documenting accuracy and completeness. Our structured workflows include reconciliation and linguistic validation to ensure conceptual equivalence across languages, particularly critical for medical terminology. This ISO-certified approach creates the audit trail required by both EU MDR and the EU AI Act, reducing compliance risks significantly.

3. Regulatory Compliance for AI-Generated Medical Translations

Pharmaceutical companies face extraordinary demands for regulatory submissions to the European Medicines Agency (EMA) and national regulatory authorities. Companies must manage complex regulations that differ across countries, rapid changes to guidelines, and potential inconsistencies in interpreting regulatory requirements.

The Challenge

Pharmaceutical translation encompasses marketing authorization applications, clinical trial protocols and reports, patient information leaflets, summary of product characteristics (SmPC), periodic safety update reports, and pharmacovigilance documentation. The EU AI Act's August 2026 deadline means that any AI-assisted translation of these documents must now comply with transparency and documentation requirements. Companies using machine translation without proper human oversight risk regulatory delays that can cost millions in lost revenue.

The Solution

SimulTrans' 40 years of experience in life sciences translation enables us to navigate complex pharmaceutical requirements while ensuring EU AI Act compliance. Our medical subject-matter experts combine deep therapeutic area knowledge with regulatory expertise. We provide end-to-end services including linguistic validation of AI-translated content, reconciliation of translated clinical terms, certificates of translation for regulatory submissions, and documented quality assurance processes. Our ISO 9001, ISO 17100, and ISO 18587 certifications demonstrate our commitment to quality processes that meet both EMA requirements and the EU AI Act's documentation obligations. Furthermore, we maintain an Information Security Management System (ISMS) in accordance with the global ISO27001 standard.

4. Accelerating Time to Market with Human Review of AI-Generated Medical Translations

Clinical trials conducted in Europe require extensive multilingual documentation, including informed consent forms, patient questionnaires, case report forms, and safety communications. The U.S. Food and Drug Administration (FDA) and EMA both emphasize the critical importance of accurate translation in patient materials. 

The Challenge

Contract research organizations (CROs) and pharmaceutical sponsors must ensure that all patient-facing materials are translated accurately. The EU AI Act adds complexity: if machine translation is used to accelerate timelines, companies must document human oversight processes. According to Section 1557 of the Affordable Care Act and similar EU regulations, patients have the right to understand medical information in their preferred language, making translation quality a matter of both compliance and patient safety.

The Solution

SimulTrans specializes in clinical trial translation with a focus on regulatory compliance. Our translators are humans with medical subject-matter expertise who understand both scientific terminology and patient communication needs. We provide back translation services conducted by independent linguists to verify accuracy, certificates of translation for ethics committees and regulatory authorities, and cultural adaptation to ensure patient comprehension across diverse populations.  This ISO-certified approach ensures compliance with the EU AI Act.

5. Scalable Compliance for Ongoing Medical Content Updates 

Medical companies face continuous translation needs for product updates, regulatory amendments, marketing materials, training content, and digital health applications. According to recent medical device market research, the global medical devices market is projected to reach USD 1,146.95 billion by 2034, driving unprecedented demand for multilingual content.

The Challenge

As medical organizations scale their international presence, they need translation solutions that balance speed, cost, and compliance. The EU AI Act complicates this balance by requiring documentation and human oversight for AI-generated content. Companies must develop processes that can handle large volumes while maintaining the audit trails required for regulatory inspections. Many organizations struggle with inconsistent terminology across markets, version control challenges, and a lack of integration between translation and regulatory systems.

The Solution

SimulTrans provides scalable, compliant translation through advanced technology integration and proven processes. Our ISO 18587-certified AI-assisted translation workflow combines machine translation engines optimized for medical content with expert human post-editing. We customize AI machine translation engines for your specific terminology and content types, integrate with your content management systems through secure connectors, and maintain translation memory to ensure consistency and reduce costs on recurring content. Our online portal provides real-time project visibility and collaboration. Most importantly, our process creates the documentation required by the EU AI Act while delivering translations 40-60% faster than traditional human translation alone.

Why Choose SimulTrans for EU AI Act Compliant Medical Translation

SimulTrans stands at the intersection of translation excellence and regulatory compliance, uniquely positioned to help medical organizations navigate the EU AI Act's requirements.

Proven ISO Certifications Ensuring Quality and Compliance

SimulTrans holds three critical ISO certifications that directly support EU AI Act compliance:

• ISO 9001 Certification: Our quality management system ensures consistent processes, documented workflows, and continuous improvement. This certification demonstrates that we have well-documented procedures that we follow consistently, creating the audit trails required by regulators.
• ISO 17100 Certification: This translation-specific standard requires qualified linguists, structured translation workflows, mandatory revision by a second linguist, and comprehensive project management. Our translators meet strict education and experience requirements, ensuring expertise in medical translation.
• ISO 18587 Certification: This standard specifically addresses human-post-editing of machine translation, the exact process required for EU AI Act compliance. Our certified approach ensures that AI-generated translations are refined by a linguist to meet professional standards for accuracy, tone, and cultural appropriateness.

Additionally,  SimulTrans maintains an Information Security Management System (ISMS) in accordance with the global ISO27001 standard. These certifications are not merely credentials—they represent audited, proven methodologies that create the documentation and oversight required by Article 50 of the EU AI Act. We provide our customers with copies of our annual ISO certifications upon request.

Four Decades of Medical Industry Expertise

SimulTrans has built deep expertise in medical device, pharmaceutical, biotechnology, and life sciences translation over 40 years since its 1984 founding. Our track record includes:

• Hundreds of successful medical device translation projects meeting EU MDR requirements
• Pharmaceutical regulatory submissions to EMA and national authorities
• Clinical trial translations for major CROs and pharmaceutical sponsors
• A 97% customer satisfaction rate in 2025, demonstrating our commitment to quality and service

We work with many translation services because of contractual agreements with our clients. When we get to choose the translation vendor, we always choose SimulTrans because of the quality of the work and the project management.—Signant Health

Full Range of Medical Translation Services

• Advanced AI Translation with Human Post-Editing: Our ISO 18587-certified process combines machine translation efficiency with human expertise, delivering translations 40-60% faster while maintaining EU AI Act compliance.
• Back Translation Verification: Independent linguists perform back translation to identify any mistranslations or ambiguities, ensuring 100% accuracy for critical medical content.
• Certificates of Translation: We provide signed certificates verifying that translations are true, accurate, complete, and correct, meeting regulatory requirements.
• Linguistic Validation: Our reconciliation and validation methodologies ensure conceptual equivalence across languages, critical for patient-reported outcomes and clinical assessments.
• Desktop Publishing and Localization: We deliver fully formatted documents in any format, ready for regulatory submission.

Everything, as always, was excellent in their professionalism, and above all, the service. Thanks to the project manager, who is always attentive and closely monitors everything.—Inyección

Strategic Advantages of Choosing SimulTrans for EU AI Act-Compliant Translation

• Audit-Ready Documentation: Our ISO-certified processes generate comprehensive records of every translation step, supporting the EU AI Act's documentation obligations. During regulatory inspections, you can demonstrate systematic human oversight of all AI-generated content.
• Risk Mitigation: By ensuring that all AI-generated translations undergo expert human post-editing, we eliminate the need for AI disclosure labels while maintaining translation efficiency. This reduces compliance complexity significantly.
• Unbiased Advice: As a privately-owned company, SimulTrans provides recommendations based solely on your needs, not investor demands. We honestly assess whether your content is suitable for AI-assisted translation and recommend the most cost-effective approach.
• Security and Confidentiality: Our employees receive comprehensive training in IT security and cybersecurity. We implement strict NDAs and encryption to protect your confidential medical data and intellectual property.
• Sustainability Commitment: SimulTrans maintains environmental, social, and governance (ESG) credentials, including climate reporting, demonstrating our commitment to responsible business practices.

SimulTrans is the ideal translation partner for medical organizations seeking both regulatory compliance and operational excellence.

Next steps

• Get a free quote for your upcoming translation projects
• Request a Machine Translation Suitability Report to assess whether your content is suitable for AI-assisted translation
• Book a meeting with our medical translation experts to discuss your EU AI Act compliance strategy

Explore our medical translation resources:

• Medical Translation Services - Learn about our ISO-certified medical translation capabilities
• Advanced AI Translation Services - Discover how we combine AI efficiency with human expertise
• Quality Commitment - Review our ISO certifications and quality processes
• Blog article: The Importance of Translation Quality in Regulated Industries - Deep dive into quality requirements
• Blog article: CRO - Selecting Your Translation Partner - Guidance for clinical research organizations

Frequently Asked Questions About EU AI Act Translation Compliance

Q: What is Article 50 of the EU AI Act, and how does it affect medical translation?

A: Article 50 of the EU AI Act establishes transparency obligations for AI-generated content (including text). For medical companies using machine translation, this means you must either disclose that the content was artificially generated or demonstrate comprehensive human oversight. SimulTrans' ISO 18587-certified post-editing process provides the documented human review required to comply with Article 50, eliminating the need for disclosure labels. Our process creates audit trails showing that qualified linguists reviewed and refined all AI-generated translations.

Q: When is the EU AI Act compliance deadline?

A: The EU AI Act's main compliance deadline is August 2, 2026, at which point transparency obligations for AI-generated content become fully enforceable. However, certain provisions already apply, and companies should begin implementing compliant processes now.  Medical organizations need to assess their translation workflows immediately and implement documented quality assurance processes. Starting early ensures you have time to optimize processes and train teams before the deadline.

Q: Can we still use machine translation for medical device IFUs and regulatory documents?

A: Yes, you can use machine translation, but it must be combined with human post-editing and proper documentation. Raw machine translation output without human review is not acceptable for compliance-sensitive medical content under the EU AI Act. SimulTrans' approach combines AI machine translation engines optimized for medical terminology with ISO 18587-certified human post-editing. This delivers the speed and cost benefits of machine translation while ensuring accuracy and creating the documentation required for regulatory compliance.

Q: What are ISO 17100 and ISO 18587 certifications, and why do they matter?

A: ISO 17100 is an international standard for translation services that ensures qualified translators, structured workflows, mandatory revision, and proper project management. ISO 18587 specifically addresses post-editing of machine translation, defining requirements for human review of AI-generated content. Together, these certifications demonstrate that a translation provider has proven, audited processes for delivering high-quality translations. For EU AI Act compliance, ISO 18587 certification is particularly important because it documents systematic human oversight of machine-generated content, satisfying Article 50's requirements.

Q: How long do medical translation projects take?

A: Medical translation project delivery depends on word count, complexity, and team size. Each SimulTrans translator translates approximately 2,000 words per day, and our translators work simultaneously across multiple languages, so adding target languages doesn't significantly impact timelines. For urgent projects, we can scale your translation team to meet tight deadlines. Our AI-assisted translation with post-editing can accelerate timelines by 40-60% compared to traditional human translation alone, while maintaining quality and compliance.

Q: What is back translation, and when is it needed?

A: Back translation is the process where an independent linguist translates content back to the source language without seeing the original document. This helps identify mistranslations, missing words, or ambiguities caused by language nuances. Back translation is commonly required for clinical trial documents, patient-reported outcome instruments, informed consent forms, and other materials where regulatory authorities or ethics committees need verification of accuracy. SimulTrans provides back translation conducted by independent linguists who were not involved in the forward translation.

Q: How much do medical translation services cost?

A: Medical translation costs vary by language, with pricing typically corresponding to the cost of living in target countries. For example, translation into Simplified Chinese costs approximately one-third of translation into Swedish. SimulTrans provides significant discounts based on repeated text by leveraging translation memory—you don't pay the full price to translate the same content. Document formatting costs are typically calculated per page. Our AI-assisted translation with post-editing typically costs 40-60% less than traditional human translation alone. Contact SimulTrans for a customized quote based on your specific requirements.

Q: What makes SimulTrans different from other translation providers?

A: SimulTrans combines several unique advantages: 40 years of medical industry experience dating back to 1984, triple ISO certification (9001, 17100, and 18587) demonstrating proven quality processes, medical subject-matter expert translators with relevant degrees and extensive experience, a 97% customer satisfaction rate in 2025, unbiased advice as a privately-owned company, comprehensive security training and protocols, and proven methodologies including reconciliation and linguistic validation. Most importantly, our ISO 18587-certified approach to AI-assisted translation uniquely positions us to help companies achieve EU AI Act compliance while maintaining efficiency and controlling costs.

Q: Can SimulTrans assess whether my content is suitable for machine translation?

A: Yes. SimulTrans can evaluate whether your medical content is suitable for AI-generated translation or neural machine translation, and determine what level of human post-editing would be necessary to achieve publishable quality. We follow ISO 18587 standards and can customize neural machine translation engines for your specific content. Request a Machine Translation Suitability Report to receive an honest, professional assessment of whether AI-assisted translation is appropriate for your materials. Machine translation works well for most medical content types except highly creative marketing copy that relies on cultural context.

Q: What is linguistic validation, and when is it required?

A: Linguistic validation is a specialized process that ensures translated content is linguistically accurate, but it also maintains conceptual equivalence across languages. It typically involves forward translation by multiple translators, reconciliation of differences, back translation, cognitive debriefing with native speakers in the target population, and final review. Linguistic validation is required for clinical trial instruments, patient-reported outcomes used in regulatory submissions, and other materials where semantic and conceptual equivalence is critical. SimulTrans provides comprehensive linguistic validation services following internationally recognized methodologies.

Q: What industries does SimulTrans serve?

A: SimulTrans specializes in several industries, such as technology, education, and medical, with experience in these medical sectors:  device manufacturers, pharmaceutical companies, biotechnology firms, contract research organizations, medical diagnostics companies, veterinary medicine, and life sciences organizations. Our 40 years of experience in these regulated industries means we understand the unique compliance requirements, terminology challenges, and quality expectations of medical organizations. Our translators have relevant degrees and extensive experience in specific therapeutic areas and regulatory frameworks, ensuring accurate and compliant translations.

About SimulTrans

SimulTrans is a leading global content solutions provider. With 40 years of experience, SimulTrans has enabled thousands of organizations to provide high-quality multilingual content to customers worldwide.

SimulTrans holds ISO 9001, ISO 17100, and ISO 18587 certifications and maintains an Information Security Management System (ISMS) in accordance with the global ISO27001 standard,  demonstrating our commitment to proven quality processes. Our private ownership allows us to focus exclusively on customer needs and quality excellence, rather than investor demands. We maintain a 97% customer satisfaction rate in 2025.

Our services include advanced AI translation with human post-editing, traditional human translation, back translation verification, linguistic validation, multilingual desktop publishing, website translation, eLearning localization, video and audio voiceovers,  software localization, and regulatory consulting. We translate all types of content into over 100 languages.

• Visit our website: simultrans.com/medical-translation
• Request a quote: simultrans.com/quote
• Book a meeting: simultrans.com/contact