𝘈𝘱𝘱𝘳𝘰𝘹 𝘳𝘦𝘢𝘥 𝘵𝘪𝘮𝘦: 7 𝘮𝘪𝘯𝘴🕒
It isn't an overstatement to say that medical translation services sit at the intersection of language, healthcare and patient safety.
From clinical trial documentation and pharmaceutical packaging to patient information leaflets and discharge summaries, medical content must be translated, of course, with complete accuracy.
Unlike some other industries, inaccuracies in translation do not carry simply reputational risks. In healthcare, they can have direct consequences for diagnosis, treatment and regulatory compliance.
To reiterate, medical translation is categorically not the same as general business translation, as it demands familiarity with complex clinical terminology and alignment with UK or global regulatory frameworks, including Medicines and Healthcare products Regulatory Agency (MHRA) requirements and NHS accessibility standards.
In this guide, we explore what medical translation services involve, the risks organisations must manage and how to select a trusted, ISO-certified provider capable of supporting compliant healthcare communication.
What are medical translation services?
Quite simply, medical translation services involve the specialist translation of clinical, pharmaceutical, life sciences and wider healthcare materials. With translation being the conversion of text from one language to another.
Examples of materials covered:
- Patient information leaflets
- Clinical trial documentation
- Informed consent forms
- Medical device IFUs
- Regulatory submissions to the MHRA
- Pharmaceutical packaging and labelling
- Public health communications
In each case, the translated content must preserve clinical accuracy and regulatory intent.
How medical translation specifically differs from general translation
Medical translation is fundamentally different from general translation.
General business translation may focus on marketing, corporate communications or operational documentation. And, while accuracy and compliance remain important, in a sense, the risk profile is typically lower.
Medical translation, by contrast, operates within a safety-critical and highly regulated environment. Errors can lead to:
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Misinterpretation of dosage instructions
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Incorrect use of medical devices
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Patient misunderstanding of treatment risks
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Regulatory non-compliance
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Legal liability
In addition, projects should follow a documented workflow that includes revision by a second qualified linguist and clear terminology management processes.
Regulatory expectations: MHRA and clinical documentation
The Medicines and Healthcare products Regulatory Agency (MHRA) oversees the regulation of medicines and medical devices in the UK.
Patient-facing materials — such as patient information leaflets, clinical trial documents and informed consent forms — must be translated accurately when they are intended for non-English readers or multinational clinical studies.
The goal is to ensure that trial participants and patients receive clear, comprehensible information before use or consent. Qualified translators are generally expected to handle these tasks and documentation should be version-controlled and demonstrable for audit or regulatory review.
In clinical research, translation obligations can extend to recruitment materials, informed consent forms and other participant-facing content, particularly under UK clinical trial frameworks modelled on International Council for Harmonisation Good Clinical Practice (ICH-GCP) principles.
Accessible Information Standard (AIS) and patient communication
For NHS and publicly funded adult social care services, the Accessible Information Standard (AIS) mandates that accessible information meeting individual communication needs must be provided. This includes identifying when translation or communication support is necessary so that patients with disabilities or impairments can understand information about services and make informed decisions.
While AIS primarily focuses on meeting disabled people’s communication needs rather than mandating translation for every document, it underlines the importance of accessible multilingual communication within clinical and administrative settings.
Additional formats include large print, braille, Easy Read, audio formats and British Sign Language (BSL), alongside professional communication support where needed (for example, via medical interpreters or advocates).
Example scenarios include:
- A patient who is blind or has sight loss may need correspondence in large print or braille — video content would also need voice-over and possibly audio description
- Someone whose first language isn't English will require translated materials and an interpreter
- Someone with a learning disability may require information in Easy Read to make complex healthcare instructions easier to understand
- Patients who use British Sign Language (BSL) are entitled to communication support through qualified interpreters or BSL video resources
Regarding formats like braille and BSL, however, please note that blind or deaf people don't always use these alternative formats.
Under the AIS, healthcare providers should ask patients about their communication needs, clearly record those needs in clinical records, and take appropriate steps to meet them.
This standard complements and, in many cases, reinforces obligations under the UK Equality Act 2010, which requires reasonable adjustments, such as translation, interpretation and alternative formats, to ensure people can access services and information on an equal basis.
GDPR and patient data security
Medical translation inherently involves handling sensitive personal data, which in the UK is governed by the UK General Data Protection Regulation (GDPR) and the Data Protection Act 2018.
These legal frameworks require organisations to process personal data lawfully, transparently and securely. In practice, this means that medical translation providers must implement appropriate technical and organisational measures to protect patient information throughout the translation process.
Information security standards such as ISO/IEC 27001 (Information Security Management Systems) provide a structured approach to managing and mitigating security risks associated with sensitive data. ISO 27001 certification demonstrates that a provider has established processes to protect data confidentiality, integrity and availability — a critical consideration in healthcare contexts where patient data and clinical documentation are at stake.
Welsh translation in NHS Wales
In Wales, bilingual healthcare communication is a statutory requirement.
Under the Welsh Language (Wales) Measure 2011, public bodies, including NHS Wales organisations, have a legal duty to provide services in both Welsh and English. Welsh must not be treated less favourably than English, and public-facing materials must be available bilingually.
This legislation is enforced through Welsh Language Standards, which set out specific duties for health boards and NHS bodies across Wales.
NHS Wales organisations are required to ensure that information is available in Welsh across multiple communication channels. This includes:
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Public-facing documents and forms
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Letters and correspondence
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Websites and digital content
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Telephone communications
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Patient information materials
Welsh language content should be available at the same time as English content, rather than being provided only upon request as is usually the case with other medical translation services.
The role of technology and terminology management in medical translation
Medical terminology must remain aligned across all materials and public health communications. Inconsistent wording can cause confusion, particularly where dosage instructions, contraindications or safety warnings are involved.
Professional medical translation services therefore rely on structured technology, including:
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Translation Memory (TM) to ensure consistent terminology across recurring documents
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Terminology management systems to maintain approved clinical glossaries
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A secure Translation Management System (TMS) to provide workflow visibility and audit trails
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Controlled use of AI-assisted tools, always subject to human revision under ISO 17100 workflows
Translation Memory is especially valuable in healthcare environments where updates to documents are frequent. It ensures that previously approved medical terminology is reused consistently, supporting both quality and efficiency, as well as long-term cost savings.
However, technology (especially AI translation) should never replace specialist human oversight. In medical contexts, subject-matter expertise and structured revision processes remain essential.
Generally, in medical translation, fully human translation and multi-step review workflows should be used. In some cases, machine translation with post-editing may be used.
Why Desktop Publishing (DTP) is also essential
One area that is often overlooked in medical translation is multilingual Desktop Publishing (DTP).
Healthcare documentation is rarely plain text. It frequently includes:
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Complex tables and dosage charts
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Diagrams and medical illustrations
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Regulatory disclaimers
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Branded templates
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Packaging layouts
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PDF, InDesign or XML files
For pharmaceutical companies and medical device manufacturers in particular, accurate formatting is just as important as accurate translation. Regulatory bodies expect documentation to be clear and professionally presented.
Advice on choosing a medical translation company
Given the risks associated with healthcare communication, organisations should apply rigorous procurement standards when selecting a language service provider.
Key considerations include:
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ISO 17100 certification for translation quality
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ISO 9001 certification for quality management
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Experience in medical and regulated sectors
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Secure handling of patient data
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Access to subject-matter expert linguists
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Dedicated project and account management
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Multilingual DTP capability
Conclusion
Medical translation services are ultimately about protecting patient safety, supporting regulatory compliance and ensuring equitable access to healthcare information.
From MHRA-aligned documentation and NHS Accessible Information Standard requirements to Welsh language obligations in NHS Wales, healthcare organisations operate within a complex regulatory landscape.
Accuracy, confidentiality and structured quality assurance are essential. So too is professional formatting and accessibility.
Since 2006, Wolfestone has supported UK healthcare organisations with ISO-certified translation, interpreting and accessible communication services across 220+ language pairs. Every project is managed by a dedicated project manager and account manager, ensuring structured oversight without impersonal ticketing systems.
If your organisation requires medical translation services, or even interpreting and accessible healthcare documentation, our team can provide a free consultation and quote tailored to your requirements.
𝘒𝘦𝘪𝘳𝘢𝘯 𝘩𝘢𝘴 𝘣𝘦𝘦𝘯 𝘸𝘳𝘪𝘵𝘪𝘯𝘨 𝘢𝘣𝘰𝘶𝘵 𝘭𝘢𝘯𝘨𝘶𝘢𝘨𝘦 𝘴𝘰𝘭𝘶𝘵𝘪𝘰𝘯𝘴 𝘴𝘪𝘯𝘤𝘦 2021 𝘢𝘯𝘥 𝘪𝘴 𝘤𝘰𝘮𝘮𝘪𝘵𝘵𝘦𝘥 𝘵𝘰 𝘩𝘦𝘭𝘱𝘪𝘯𝘨 𝘣𝘳𝘢𝘯𝘥𝘴 𝘨𝘰 𝘨𝘭𝘰𝘣𝘢𝘭 𝘢𝘯𝘥 𝘮𝘢𝘳𝘬𝘦𝘵 𝘴𝘮𝘢𝘳𝘵. 𝘏𝘦 𝘪𝘴 𝘯𝘰𝘸 𝘵𝘩𝘦 𝘏𝘦𝘢𝘥 𝘰𝘧 𝘔𝘢𝘳𝘬𝘦𝘵𝘪𝘯𝘨 𝘢𝘯𝘥 𝘰𝘷𝘦𝘳𝘴𝘦𝘦𝘴 𝘢𝘭𝘭 𝘰𝘧 𝘰𝘶𝘳 𝘤𝘰𝘯𝘵𝘦𝘯𝘵 𝘵𝘰 𝘦𝘯𝘴𝘶𝘳𝘦 𝘸𝘦 𝘱𝘳𝘰𝘷𝘪𝘥𝘦 𝘷𝘢𝘭𝘶𝘢𝘣𝘭𝘦, 𝘶𝘴𝘦𝘧𝘶𝘭 𝘤𝘰𝘯𝘵𝘦𝘯𝘵 𝘵𝘰 𝘢𝘶𝘥𝘪𝘦𝘯𝘤𝘦𝘴.