Understanding the impact of the European Accessibility Act on Medical Devices

The European Accessibility Act (Directive (EU) 2019/882) (the “EAA”) came into effect in June 2025 and has quietly revolutionised digital accessibility in the EU. The EAA establishes a distinct regulatory regime that harmonises accessibility requirements for many day-to-day consumer products and services, such as computers, smartphones, and tablets, electronic communications, and e-commerce and its scope may extend to medical devices. 

The EAA is enforced through the laws of each of the 27 EU Member States so it is important for any providers of services and manufacturers, importers and distributors or products subject to the EAA to identify and monitor national EAA laws which apply to markets where they operate in the EU. 

Which products and services may be relevant to medical devices?

The EAA applies to specific consumer products and services across a range of sectors. 

While medical devices within the meaning of the Medical Device Regulation (Regulation (EU) 2017/745) are not a product category explicitly within scope of the EAA, the EAA’s accessibility requirements may still apply if the medical device or its accessories fall within scope of any of the specific EAA product and service categories. 

Examples of product and service categories covered by the EAA that may impact on medical devices or services delivered via such devices include:

• Online retail and subscription-based apps: Commercial web or app-based health services which are medical devices provided directly to consumers must be EAA-compliant. The EAA defines an ‘e-commerce service’ as a service provided “at a distance, through websites and mobile device-based services by electronic means and at the individual request of a consumer with a view to concluding a consumer contract”.
• Medical and healthcare apps: Features and functionality of web or app-based health services provided to consumers on a subscription or other payment basis on a device may also be captured by the EAA as an ‘e-commerce service’.
• Electronic communications equipment: Devices for patient-healthcare provider communication, including those used for remote monitoring, remote administration of drugs or treatment, or virtual consultations may qualify as ‘consumer terminal equipment with interactive computing capability, used for electronic communications services’, a product category covered by the EAA. The term “interactive computing capability” includes functionality that supports human-device interaction capable of processing and transmitting data, voice or video.
• Electronic communications services: Digital communications systems or infrastructure for transmitting medical or health data back and forth to a consumer may be classified as an ‘electronic communications service’ for the purposes of the EAA. The definition of an ‘electronic communications service’ under the EAA has the same meaning as in the European Electronic Communications Code (Directive (EU) 2018/1972) so it is broad definition, and includes both traditional and modern forms of communication.
• Emergency communications: Any operations that interface with systems handling emergency calls to the single European emergency number ‘112’ should be aware of accessibility requirements which may impact them, such as real time voice, video and text communication support for contacting emergency services.
• Assistive technologies: The EAA also presents an opportunity for medical devices that are assistive technologies because the EAA’s accessibility requirements stipulate that in-scope products and services must be compatible with current and future assistive technologies.

Since 28 June 2025, all products and services covered by the EAA must meet its accessibility requirements. However, when making the changes required by the EAA you should take care to ensure continued compliance with the Medical Device Regulation and other regulatory obligations that arise in relation to the product or service. Proactive engagement to address all laws impacting on product and service design is essential to avoid compliance gaps. We recommend that cross-functional teams, including legal, regulatory, and design specialists, collaborate early in the product development process to identify legal obligations, in order to resolve potential conflicts successfully.  

What are the accessibility requirements?

There are now mandatory common accessibility requirements which apply to all in-scope products and services, and further specific accessibility requirements for certain categories of products and services. 

Products and services must be designed to maximise accessibility for those with disabilities and comply with legal requirements on the provision of information, functionality, and support services. These legal accessibility requirements are based on the ‘POUR’ principles (perceivability, operability, understandability, and robustness). The accessibility requirements include providing:

• Accessible information: Access to all relevant information about service or product including accessibility features and facilities.
• Accessible functionality:
  • Content must be available in more than one sensory channel (alternate sensory channels may be provided by assistive technology when possible);
  • Text must be displayed in a font of adequate size and shape, sufficient contrast, and with adjustable spacing between letters, lines, paragraphs;
  • Content must be understandable;
  • Provide alternative forms of presentation for non-textual content.
• Customer support services: Where available, customer support services (e.g. help desks, call centres, technical support, relay services and training services) must provide information on the accessibility of the product or service. 

Next steps and how we can help

The EAA’s application across the EU is fortified by a range of new supervision and enforcement powers, including consumer complaints and regulatory sanctions and fines. To avoid unwanted regulatory attention or consumer legal actions, we recommend:

• Assessing whether your medical device or its accessories are a product or service within scope of the EAA, and
• If the device or part of it is identified as being an in-scope product or service then:
  • Familiarise yourself with the accessibility requirements applicable to each in-scope element.
  • Identify which jurisdictions are relevant to your product or service, including whether any additional local requirements apply through national implementing laws.
  • Conduct a gap analysis to identify whether applicable accessibility requirements are met or whether further measures are required.
  • Notify any non-compliance or reliance on derogations to the relevant regulators where required to do so.
  • Routinely revise relevant internal policies and procedures, and provide training to key personnel - including those involved in developing or designing covered products or services, as well as customer support teams assisting users of these offerings.
  • Review your vendor and service provider contracts to ensure responsibility for complying with the accessibility requirements is appropriately allocated through the supply chain.
  • Update your internal design, compliance and legal procedures and policies to take account of your statutory obligations.

Further resources

For a broader overview of the EAA and to see a snapshot of the products and services it covers, recommended next steps and enforcement actions, see our infographic here.

For more information on the EAA, please visit our dedicated site where you can find our articles on the EAA including:

• Time to check-out… the European Accessibility Act and its impact on travel, hospitality and leisure
• European Accessibility Act: Focus on Financial Services
• A guide to navigating the European Accessibility Act for online retailers, service providers and platforms
• European Accessibility Act: is it time to update your websites, products & services to meet Europe’s accessibility requirements?

If you would like further information on whether your medical device or related services and apps are within scope of the EAA, please contact Deirdre Kilroy or Kelly Mackey. 

Information correct as of 6 January 2026.