The Impact of EAA Compliance on Life Sciences: Why Translation and Localisation Matter 

Accessibility isn’t just about technology or design; it’s about making sure everyone, in every language, can understand and use the information that matters most. The European Accessibility Act (EAA) represents a transformative shift in ensuring that all citizens, regardless of ability, can access products and services across the EU. For life sciences organisations, especially those producing medical devices, pharmaceuticals, and digital health platforms, EAA compliance introduces a new set of responsibilities. 

Among these, translation and localisation play a crucial role. While much of the discourse on accessibility focuses on design and technology, language access is equally vital. In this blog post, we explore the intersection of the EAA and language services, offering a consultative look at how life sciences organisations can align their multilingual strategies with regulatory expectations. 

What is the European Accessibility Act? 

The European Accessibility Act, adopted in 2019 and fully enforceable from June 2025, aims to harmonise accessibility requirements across EU member states. It covers a broad spectrum of products and services, including: 

• Computers and operating systems
• Self-service terminals (e.g. ATMs) 
• Banking and e-commerce services
• E-books and reading software
• Telecommunication and digital content 
• Certain medical devices and health-related digital services

The Act’s objective is to eliminate barriers for people with disabilities, enhance cross-border trade, and foster inclusive innovation. 
Though not every life sciences product falls under direct regulation, any offering involving digital interaction, patient communication, or consumer information must now account for accessibility as an embedded requirement. 

Beyond Buttons and Screens: Language Access in EAA Compliance 

It’s tempting to interpret the European Accessibility Act solely through the lens of digital and physical usability, such as screen-reader support, voice control, or touch-free navigation. But accessibility also means ensuring that people can understand the information provided. 

For life sciences companies, this goes far beyond websites and apps. It includes: 

• Instructions for use, labels, and patient leaflets that are understandable and available in multiple EU languages
• Digital platforms like patient portals and mobile apps that support accessible, multilingual communication
• Consent forms, safety information, and clinical documentation written in plain, inclusive language

Simply put: if your materials aren’t linguistically accessible, they aren’t accessible at all. Translation and localisation aren’t just supportive tasks — they are central to EAA compliance. But achieving compliance requires more than basic translation services. Language teams must work in close collaboration with accessibility experts, UX designers, and regulatory stakeholders. 

Here are four areas where language access directly intersects with the EAA’s goals: 

1. Plain Language and Comprehension 

One of the EAA’s fundamental aims is to ensure critical information is understandable to all users, regardless of education level, native language, or cognitive ability. That means: 

• Translating into plain, jargon-free language that suits the reading level of the target audience
• Applying health literacy principles across all language outputs
• Preserving regulatory accuracy while ensuring the content remains clear and navigable

A high-quality translation isn’t just correct, it must also be easy to read, inclusive, and actionable. 

2. Multimodal Delivery and Technical Compatibility 

Translation is not just about content; it’s about how that content is delivered. Multilingual accessibility must be embedded in all formats: 

• Subtitles and captions for video content in all required EU languages
• Text alternatives for images, infographics, and multimedia
• Translations formatted to work with screen readers and voice-output devices

Digital health tools, mobile apps, and websites must integrate these localisation features from the start, not as an afterthought. 

3. Cultural and Linguistic Relevance 

EAA compliance also extends to cultural appropriateness. A translated user interface or medical label that uses unfamiliar idioms or culturally irrelevant references can lead to misunderstanding or even risk to patient safety. Effective localisation includes: 

• Adapting units of measure, dates, and terminology to local conventions
• Ensuring examples and phrasing reflect the user’s cultural context
• Avoiding region-specific idioms unless they are clearly understood across the market

It’s not enough to translate. Your content must be locally resonant and safe to interpret. 

4. Cross-Functional Collaboration 

EAA compliance is not a one-off task; it’s an ongoing, cross-functional effort. Translation and localisation teams should be embedded early in the product lifecycle and regulatory planning to: 

• Partner with developers to ensure accessible code supports multilingual delivery
• Integrate localisation into accessibility audits and QA testing
• Build ongoing feedback loops as requirements and user needs evolve

Why It Matters: Legal and Regulatory Risk

The EAA is not just advisory; it is enforceable. Member states are responsible for implementation, and non-compliance can result in: 

• Product recalls or denied market access
• Financial penalties and litigation
• Reputational damage in competitive EU markets

For life sciences companies, even seemingly minor oversights (such as failing to provide accessible patient information in all required languages) can have significant regulatory consequences. 

Building a Compliance-Ready Localisation Strategy

So, how can life sciences organisations prepare their language infrastructure for the EAA? 

• Conduct a multilingual accessibility audit: Review all content (digital, printed, and audiovisual) for both linguistic and technical accessibility gaps.
• Involve language services early: Engage translation and localisation professionals at the design and development stage, not just post-production.
• Prioritise accessible workflows: Incorporate tools and processes that support screen-reader testing, audio alternatives, and readability standards across all languages.
• Partner with experienced providers: Seek language service partners who understand regulatory frameworks, including EN 301 549, ISO 17100, and WCAG 2.1, alongside the specialised demands of life sciences translation.

Language Access as a Responsibility 

The European Accessibility Act reflects a broader shift toward equity, inclusion, and universal design across Europe. For life sciences organisations, translation and localisation are not optional add-ons; they are critical elements of compliance, patient safety, and ethical responsibility. 

Done right, multilingual accessibility isn’t just about checking boxes. It’s about ensuring that everyone, regardless of language or ability, has equal access to vital health information and services. 

Is your organisation prepared to meet EAA compliance through accessible, multilingual communication? Contact Avantpage Life Sciences to discuss how to ensure your translation and localisation strategies align with both regulatory requirements and the principles of inclusive design. 

Let’s make accessibility the standard for everyone and in every language.