EN 301 549 is the European standard for digital accessibility requirements for ICT products and services, and it references WCAG 2.1 level AA as its core web content requirement — it is the technical standard the European Accessibility Act points to for websites.
EN 301 549 sets accessibility requirements across a range of ICT, not just websites, but for web content specifically it incorporates WCAG 2.1 AA as the applicable success criteria. Meeting WCAG 2.1 AA is, for practical purposes, meeting the web-content portion of this standard.
The European Accessibility Act references EN 301 549 as the harmonised standard demonstrating compliance — see does the EAA apply to pharma websites for whether the EAA itself applies to your company.
Contrast, keyboard operability, semantic structure, and accessible forms and documents, verified through both automated and manual testing — see accessibility compliance for how we audit and remediate against it.
No, EN 301 549 is broader — it’s the European standard for accessible ICT procurement, and it incorporates WCAG 2.1 AA as its web content requirement alongside separate requirements covering hardware, software, and other ICT products that don’t apply to a website. For a pharma company, the web content section is usually the relevant part, with the rest of the standard applying elsewhere.
EN 301 549 currently still references WCAG 2.1 AA as its baseline, even though WCAG 2.2 has since been published with additional success criteria. Building to 2.2 typically satisfies 2.1 as well, so many organisations target the newer version regardless of which one the regulation formally cites. See WCAG 2.1 vs 2.2 for how the two versions differ in practice.
Formal certification requirements vary by country, by whether you’re a public or private entity, and by sector-specific rules that may apply on top of the general standard. There’s no single EU-wide certification process that applies uniformly. Your legal counsel can confirm the specific compliance obligation and any documentation or attestation required in your market — this isn’t something to assume from general guidance.
Yes, the standard covers a broad range of ICT, including mobile applications, not only websites — the accessibility requirements extend to software interfaces generally. If your company distributes a patient or HCP-facing app alongside your website, the same underlying WCAG-based criteria for web content typically apply to the app’s interface, though the specific technical implementation differs between web and native platforms.
Tell us what you have and we will check it against this standard properly.