Medical device teams rarely struggle with what their product does. The friction usually comes from how information is delivered—labels, IFUs, app screens, eIFUs, training media—and whether users and patients can understand and use the device safely in their own language and with their own abilities. In other words, are they delivering accessible medical devices?

In this article, we share the practical side of accessibility and language for:

• Medical Device AI (MDAI)
• Software as a Medical Device (SaMD)
• Electromedical Devices (EMD)

The goal? Help you unblock submissions, reduce post-market risk, and accelerate adoption worldwide.

How Accessibility and Language Shape Market Access

Accessibility and localization directly impact regulatory approval, procurement success, patient safety, and commercial performance.

Regulators Expect It

Across major regions, manufacturers must ensure that information supplied with the device is:

• Clear
• Accurate
• Available in the official language(s) of the target market

This applies to labels, IFUs, on-device text, and increasingly, digital interfaces.

Procurers Verify It

Hospitals and public institutions are raising the bar. Many now require proof of digital accessibility conformance, including:

• WCAG
• Section 508
• EN 301 549

This affects apps, portals, dashboards, and eIFU platforms.

Patients Rely on It

Accessible communication directly reduces use-related risk. This includes:

• Plain language instructions
• Readable formatting
• Captions and transcripts
• High-contrast interfaces
• Screen-reader compatibility

These elements support equal access and reduce complaints and misuse.

It Pays Off

Strong localization and accessible UX:

• Reduce training overhead
• Lower support tickets
• Improve clinical adoption speed
• Strengthen real-world performance

The Essentials—What Changes by Product Type?

Accessibility and language obligations apply across all medical devices. How they show up in practice depends heavily on whether your product is software-first or hardware-first. The risk profile, regulatory focus, and user interaction model all influence what “accessible and compliant” really means.

SaMD and MDAI (Software-First)

For SaMD and MDAI, the software is the device. That means your interface is inseparable from your safety case. Every screen, notification, output, and help file contributes to how safely and effectively the product is used.

In practical terms, this means:

• The user interface, in-app messages, outputs, and help content are part of the device’s regulated information.
• For AI-driven functionality, transparency is critical. Users must clearly understand:
  • The intended use
  • The limitations
  • Any confidence indicators or uncertainty signals
  • The role of human oversight, especially for patient-facing outputs

Clarity is not just good UX—it is risk control.

Accessibility must also be built into the product architecture from the start. It cannot be layered on at the end. Teams should aim for WCAG 2.2 AA conformance across:

• Apps
• Web portals
• Clinical dashboards
• eIFU platforms

For software-first products, accessibility directly affects safe use, regulatory acceptance, and procurement eligibility. Even though the law requires 2.0/2.1, the effort is not different; you guarantee the most up-to-date access level and are ready for the next law update.

Electromedical Devices (Hardware-First)

With electromedical devices, the hardware may take center stage, but digital and informational elements still play a crucial safety role. Even when the primary function is physical, users interact with screens, controls, alerts, and documentation.

Typical digital touchpoints include:

• On-device displays
• Alarm systems
• Buttons and interface panels
• Companion apps
• eIFUs

These sit alongside traditional hardware standards for safety and essential performance. However, compliance doesn’t stop there. Manufacturers must also address:

• Usability requirements
• Information-for-use obligations
• Language availability
• Appropriate symbol usage

Accessibility in hardware products often overlaps significantly with human factors engineering. Considerations include:

• Legibility at realistic viewing distances
• Adequate contrast under clinical lighting conditions
• Tactile differentiation for controls
• Color-independent status indicators
• Alternative instruction formats, such as accessible PDFs or captioned training videos

For hardware-first devices, accessibility strengthens usability, and usability directly supports safety and regulatory defensibility.

Region-by-Region: Language & Accessibility Overview

While principles are global, requirements vary by region.

European Union

In the EU, expect:

• Labels, IFUs, safety information—and often on-device GUI—to be available in the official language(s) of each Member State where the device is marketed.
• Digital content (apps, portals, eIFUs) to align with EN 301 549 accessibility expectations, particularly for public procurement and hospital IT environments.

Planning for accessibility is increasingly essential to participate in public tenders.

United States

In the U.S.:

• English dominates labeling and IFUs.
• However, patient-facing materials in additional languages are often expected in diverse communities.
• Digital accessibility is commonly aligned with Section 508 requirements, especially in federal and institutional settings.

United Kingdom

In the UK:

• The Medicines and Healthcare products Regulatory Agency (MHRA) emphasizes clarity of information and safe usability for Software and AI as a Medical Device.
• An accessible-by-design approach directly supports regulatory expectations.

The Key to Success: Integrate Compliance into Design Controls

Accessibility and language compliance are not tasks to tack on at the end of development. The most effective approach is to embed them into your design control system from the outset. When treated as core requirements, they reduce risk, support regulatory submissions, and improve user experience across all markets.

1) Define Requirements You Can Trace

The first step is to make accessibility and language explicit design inputs rather than optional enhancements. This starts with formal documentation that auditors can follow:

• Reading levels – Specify appropriate literacy levels (for example, 6th–8th grade for patient-facing content, adjusted by region).
• Terminology control – Use approved glossaries to maintain consistent language across translations.
• GUI text as a requirement – Treat interface text like any other safety-critical element by assigning unique IDs, defining character limits, and providing context notes for translators.

Traceable requirements make it clear that accessibility and language are integral to safe use, not afterthoughts. They also simplify audits, submissions, and updates.

2) Build Accessibility by Design

Accessibility should guide product design, reducing use-related risks before they reach end users. Consider these dimensions:

Visual Design

• High-contrast text and graphics
• Scalable fonts for readability
• Consistent icons
• Color-independent states (avoid relying solely on color, e.g., “red = error”)

Structural Design

• Logical heading hierarchy for easy navigation
• Correct focus order for keyboard and assistive device users
• Keyboard and switch accessibility
• Screen-reader labels and alt text

Media Accessibility

• Captions and transcripts for all videos
• Audio descriptions for visuals that convey critical safety information

Interaction Design

• Clear error prevention mechanisms
• Safe recovery pathways for mistakes
• Confirmation steps for critical actions, especially in patient-facing apps or home-use devices

When accessibility is baked into the design, it becomes part of the device’s safety story rather than a compliance checkbox.

3) Combine Human Factors and Localization

Localization introduces additional complexity that can create new usability risks. To mitigate this:

• Include assistive technology users in formative usability studies whenever possible.
• Validate critical tasks in localized versions during summative testing for key markets.
• Monitor layout and UI issues, including:
  • Truncated or clipped text
  • Line-wrapping problems
  • Clipped buttons or controls
  • Right-to-left language formatting (if applicable)

By integrating human factors and localization, you ensure that translated content maintains the same safety and usability standards as the source language.

4) Build Content Operations You’ll Actually Use

Strong content management systems prevent confusion and maintain consistency as your product evolves. Core practices include:

Single Source of Truth

• Keep all approved content—labels, IFUs, GUI strings—under strict change control.
• Systematically propagate updates to all translated versions.

Translation Memory and Terminology Management

• Reduce translation costs
• Speed up updates
• Preserve consistent phrasing for safety-critical information

In-Context Review

• Have linguists and subject matter experts review content inside the UI, via screenshots or live builds.
• Catch layout and meaning issues early before release.

Linguistic Validation (When Needed)

• For patient-reported outcomes or similar instruments:
  • Conduct cognitive debriefing
  • Perform back-translation
  • Confirm conceptual equivalence across languages

Let’s talk!

For MDAI, SaMD, and EMD, clear language and accessible design are core to safety—and to market access. If you capture accessibility and localization as design controls, validate them with users, and govern updates through change control, you’ll reduce regulatory friction and improve real-world adoption.

Schedule a consultation with our team to pressure-test your language plan, accessibility targets, and submission-ready documentation.