Accessibility is gaining importance in the EU, not least with the European Accessibility Act (EAA, Directive (EU) 2019/882), which has applied since 28 June 2025. Two European standards are often mentioned in this context: EN 17161:2019 and EN 301 549. Both deal with accessibility, but they differ significantly in scope, technical requirements and applicability.
1. Key differences
| Aspect | EN 17161:2019 | EN 301 549 |
|---|---|---|
| Scope | Products, goods and services in all sectors; “Design for All” approach | Information and communication technology (ICT) products and services |
| Core objective | Extend the range of users so that products and services can be used by as many people as possible | Ensure that ICT hardware, software and services meet accessibility requirements |
| Products covered | All product types (industrial, consumer, medical, construction, etc.) | Computers, smartphones, software, websites, self-service terminals such as ATMs, etc. |
| Key requirements | An organisational, process-based Design for All approach throughout product development, for all users | Specific functional and technical requirements for electronic interaction, incorporating the WCAG 2.1 success criteria for web content and software |
| Nature | Process/management standard (voluntary) | Technical standard with test procedures; harmonised under the Web Accessibility Directive (EU) 2016/2102 and a key reference for the EAA |
| Testing | No specific test methods; focuses on accessibility within the design process | Detailed evaluation methods, e.g. screen reader compatibility, audio output, keyboard navigation |
| Typical sectors | All sectors (industry, consumer, healthcare, construction, banking, transport, etc.) | ICT only (websites, software, computers, smart devices) |
2. Which standard applies to which medical device?
Medical devices are not as such among the products listed in the EAA. However, accessibility and usability matter for medical devices – the MDR and IVDR require manufacturers to consider the intended users, including lay users – and accessibility may be required by customers, public procurement or the EAA where a product or service falls within its scope. Medical technology covers physical equipment, medical software and digital platforms, so the choice depends on the product type.
EN 17161 – for all types of medical devices and services
- In vitro diagnostic (IVD) devices
- Conventional medical equipment (e.g. X-ray systems, surgical instruments, monitors)
- Assistive products (e.g. wheelchairs, hearing aids)
- Hospital infrastructure (e.g. hospital beds, information systems)
- Healthcare providers (e.g. healthcare facilities, pharmaceutical companies)
Reason: the standard focuses on a Design for All approach, applies throughout the product lifecycle (design, production, delivery, use) and is not limited to ICT.
EN 301 549 – for ICT-related medical products
- Medical software and apps (e.g. telemedicine, patient management systems)
- Electronic health record (EHR) systems
- Healthcare websites and online services
- Smart medical devices (e.g. devices with screens, wearables)
Reason: the standard sets accessibility requirements for ICT and is suited to digital platforms and user interfaces in healthcare.
3. Conclusion
- EN 17161 can be applied to all medical devices – physical equipment, services and infrastructure – whereas EN 301 549 covers only ICT-related products.
- EN 17161 emphasises general Design for All principles rather than software or digital devices alone.
- If a medical device includes software, websites or e-health platforms, EN 301 549 should be considered as well to meet ICT accessibility requirements.
How EVERBIZ can help
- Accessibility assessment of medical devices based on EN 17161
- Accessibility testing of medical device software based on EN 301 549
- Regulatory review against the MDR, IVDR and, where applicable, the EAA
- Support with accessibility-related documentation alongside CE marking
Contact us to make sure your products meet current requirements and stay competitive in the EU market.
This article is for general information only and does not constitute legal advice.