Can AI support EMA-compliant medical translation? 

The life sciences sector is undergoing a significant shift as AI becomes increasingly embedded in multilingual content workflows. Tightening regulatory deadlines, expanding language coverage, and growing documentation requirements have prompted many clinical, regulatory, and quality teams to ask: 

Can AI-assisted translation be used responsibly for regulated medical content such as SmPCs, package leaflets, and other materials required under EMA or MDR/IVDR frameworks, including IFUs and patient communications? 

This article explores how AI can be used within the boundaries of regulatory compliance, and under what conditions it becomes a safe and effective solution for medical translation services. 

The role of AI in regulated medical translation 

AI-assisted translation has made substantial progress in the past two years. When used thoughtfully, it can improve speed, consistency, and scalability across a range of use cases, including: 

These benefits make AI an increasingly attractive option, especially for projects with high volume and short timelines. However, regulatory content requires more than speed, it demands precision, traceability, and full alignment with terminology and format expectations established by authorities such as the EMA, FDA, and national agencies. 

Why AI alone is not enough 

Despite its capabilities, AI still faces limitations in highly specialised domains like regulatory translation. These challenges may include: 

• Morphological complexity in languages like Hungarian or Finnish 

• Use of standardised terms such as MedDRA, EDQM, or EMA QRD templates 

• Sensitivity to phrasing and clarity, particularly in patient-facing materials 

Because of this, raw AI output is never suitable for regulatory submission. Quality, compliance, and patient safety can only be ensured when expert human review is embedded in the process. 

Human-in-the-loop: the cornerstone of safe AI translation 

AI can support translation workflows, but only under the close supervision of qualified human experts. In the context of regulated medical content, the role of human reviewers goes beyond basic post-editing: 

• They verify correct application of regulatory templates and terminology 

• They ensure alignment with product-specific references and previous submissions 

• They assess the readability and tone of patient communications 

• They provide the final layer of accountability required for compliance 

The “human-in-the-loop” approach ensures that AI improves productivity without compromising the regulatory integrity of the output. In this model, human reviewers are not simply editors, they are guardians of quality, safety, and consistency in healthcare translation services. 

Systems, not just tools: responsible AI implementation 

Effective use of AI in regulatory translation involves more than choosing the right tool. The entire system must be designed to support compliance and quality from the start. This includes: 

• Benchmarking AI models by language pair, content type, and domain to determine suitability 

• Integrating AI with existing translation memories, termbases, and client glossaries to ensure consistent terminology and phrasing 

• Establishing internal policies for when and how each tool can be used, based on content sensitivity 

This interconnected framework helps reduce post-editing effort while ensuring terminology accuracy and alignment with regulatory expectations. 

Aligning with EMA compliance and ISO standards 

While the EMA has not issued explicit guidance on the use of AI in translation, existing regulations and standards provide a clear framework for compliance. AI-assisted workflows are considered acceptable if they include proper human post-editing, transparent processes, and data protection safeguards. 

Industry standards that support responsible AI use include: 

• ISO 18587, for the post-editing of machine translation 

• ISO 13485, for quality management systems in medical device translation 

• MDR/IVDR requirements, particularly for readability and terminology consistency in IFUs and patient materials 

Organizations using AI responsibly incorporate these standards into their workflows, combining automated tools with expert human oversight and continuous quality evaluation. 

What do regulations say about AI use in translation? 

To date, no EU regulation prohibits the use of AI in medical translation workflows. The EMA and national agencies focus on the quality and compliance of the final output, regardless of the tools used. Key regulatory expectations include: 

• Human validation by qualified translators 

• Traceability of process and tool usage 

• Terminology alignment with approved reference materials 

• Transparency and data protection throughout the workflow 

When these principles are respected, AI-assisted translation can support regulatory compliance. 

Final thoughts 

AI is not a replacement for human expertise, it’s a tool that, when used responsibly, can improve the accuracy, consistency, and scalability of medical translation workflows. For regulated content, success lies in combining technological support with human accountability, robust quality systems, and standards-based validation. 

As the medical and pharmaceutical industries continue to evolve, AI will likely play an expanding role in multilingual content delivery. But for regulatory translation, one truth remains constant: compliance starts with processes, not with tools.