EAA 2026 by Sector: Which Documents Must Be Accessible, Industry by Industry

The European Accessibility Act (Directive 2019/882) has applied since 28 June 2025, and national market surveillance authorities are now more than a year into enforcement. The rule is the same for every sector; what differs is which documents it catches and which other regulations it collides with. This page states the common rule once, then covers twelve sectors: healthcare, pharma, medical devices, banks, insurance, retail, e-commerce, transport, higher education, legal, publishing and nonprofits.

The Common Rule

Scope. The EAA covers products and services offered to consumers in the EU, wherever the provider is headquartered. Article 2 names e-commerce, consumer banking and financial services, passenger transport (air, bus, rail, waterborne), e-books, electronic communications and audiovisual media services directly. Documents a customer needs in order to use a covered service — terms, statements, manuals, leaflets, confirmations — are part of that service and inherit the obligation.

Standard. The technical benchmark is EN 301 549, which references WCAG 2.1 Level AA; WCAG 2.2 AA is the current W3C recommendation and the safe target. For documents, the criteria that matter most are 1.3.1 (structure), 1.3.2 (reading order), 1.1.1 (alt text), 1.4.3 (contrast), 3.1.1 (language) and 1.4.10 Reflow: content must be usable at a 320 CSS pixel width (400% zoom) without horizontal scrolling.

The PDF problem. Fixed-layout PDF cannot satisfy 1.4.10. Tagging to PDF/UA (ISO 14289) with Acrobat Pro, CommonLook or axesPDF fixes structure, reading order and alt text, but not page geometry. A two-column A4 page at 400% zoom is roughly 3,200 pixels wide and must be scrolled sideways line by line. EPUB3, built on HTML5 and CSS, reflows by design.

Exemptions. Microenterprises (fewer than 10 employees and annual turnover or balance sheet not exceeding €2 million) are exempt for services; exceeding either threshold puts you in scope. Being a nonprofit, a university or a law firm is not an exemption. Public bodies fall under the Web Accessibility Directive (2016/2102) instead. The Article 14 disproportionate-burden exception is a documented, per-service assessment that authorities can challenge, not an opt-out. Details, fines and the 2030 transitional period are in EAA enforcement and penalties.

The practical path. Keep the PDF as the print or regulatory artefact where a format is mandated, publish an accessible EPUB3 alongside it, validate the EPUB3 with ACE by DAISY, and keep the report as evidence. The sector sections below apply that pattern to each industry’s documents.

Quick Reference

Sector	Documents in scope	Sector-specific twist
Healthcare	Discharge summaries, outpatient letters, patient packs, trial recruitment	Patients most likely to need the documents are the most likely to have low vision
Pharmaceutical	PILs, SmPCs, risk minimisation materials, patient support documents	EMA QRD templates fix the PDF layout; accessible alternative must be provided alongside
Medical devices	Instructions for Use (IFU), symbol tables, safety notices	MDR/IVDR and the eIFU regulation stack on top of the EAA
Banks and financial services	Statements, fee schedules, T&Cs, KIDs/KIIDs, prospectuses, mortgage documents	Consumer banking is a named EAA service; statements are system-generated
Insurance	Policies, certificates, PIDs, KIDs, claims forms, renewals, annual statements	PRIIPs/IDD mandate KID and PID formats; dual-format distribution
Retail	Product manuals, warranties, T&Cs, catalogues, returns procedures	Third-party supplier manuals you distribute are your exposure too
E-commerce	Catalogues, user and installation guides, T&Cs, refund policies, invoices	Named in Article 2; designed catalogues fail Reflow, simple T&Cs may not
Transport	Ticket T&Cs, timetables, booking confirmations, assistance guides, disruption notices	Named in Article 2; timetables are the hardest multi-column tables
Higher education	Course materials, handbooks, prospectuses, admissions forms, theses	Public universities already under Directive 2016/2102; EAA adds the commercial side
Legal	Engagement letters, terms of business, client guides, contracts, practice publications	Signed instruments stay as PDF; the information must still be accessible
Publishers	E-books, journal articles, reference works, backlist	E-books are named in the EAA; backlist scale makes manual remediation impossible
Nonprofits and NGOs	Annual reports, policy papers, grant guides, event programmes	Nonprofit status is not an exemption; volumes are small enough to fix cheaply

Healthcare: Hospitals and Health Systems

In scope: hospital groups and health systems, medical associations and regulatory bodies publishing guidance, and health technology companies with patient-facing documentation.

Documents: discharge summaries and outpatient letters sent digitally, hospital guides and patient information packs, clinical trial recruitment materials, clinical guidelines with dosing charts and decision trees.

Sector specifics: age-related macular degeneration, diabetic retinopathy and glaucoma are concentrated in exactly the population that receives discharge paperwork, so Reflow failures land on the readers least able to work around them. Clinical trial regulations already require participant-facing documents to be understandable; accessibility is the same obligation in a second form. Publish patient packs as PDF for printing and EPUB3 for digital access, and convert letters at the point of sending.

Pharmaceutical Companies

Documents: patient information leaflets (PILs) delivered via QR code or product site, summaries of product characteristics (SmPCs) on medicines databases, risk minimisation materials (RMMs) for patients and prescribers, patient support programme documents, clinical trial participant information sheets, plus annual, ESG and investor reports distributed to EU stakeholders.

Sector specifics: the European Medicines Agency’s QRD templates prescribe font, layout and section order for PILs and SmPCs, and those multi-column layouts cannot reflow as PDF. EMA guidance recognises the tension and recommends an accessible alternative format alongside the required one. The accessible version does not have to reproduce the QRD look; it has to carry the same content in correct structure, with the mandated section order (indication, dosage, contraindications and so on) preserved. Priority order: PILs for high-volume medicines, RMMs for high-risk medicines, patient support materials (no format constraint), then SmPCs. Portfolios of hundreds of PILs are an API job; the ACE report doubles as evidence for EMA readability expectations.

Medical Devices: Instructions for Use

Documents: IFUs for patient-facing and home-use devices (glucose monitors, insulin pumps, CPAP, home defibrillators), typically 40–80 pages of multi-column text, bordered warning boxes, numbered step tables, ISO 15223-1 symbol tables, callout diagrams and specification tables.

Regulatory stack: EU MDR (2017/745) Article 10(11) and IVDR (2017/746) Article 10(10) require IFUs in accessible form as national law demands; Commission Implementing Regulation (EU) 207/2012 sets the conditions for electronic IFUs; MDR Annex I Section 23 fixes the IFU’s content; the EAA supplies the technical standard (WCAG 2.1 AA via EN 301 549, clause 10 for non-web documents). Some notified bodies already expect PDF/UA tagging for Class IIb and III devices, and PDF/UA does not touch Reflow.

Sector specifics: keep the PDF for packaging inserts, notified body submission and regulatory filing; distribute EPUB3 from the device website, QR code and patient portal, labelled as the accessible version. Localised IFUs (27 language versions per product update) are generated programmatically, so generate the EPUB3 at the same step. File ACE reports in the ISO 13485 quality system as post-market accessible-format evidence. Convert first: implantable Class III devices and home-use devices for chronic conditions; last: professional-use-only devices.

Banks and Financial Services

In scope: retail banks, investment firms and asset managers, fintechs and neobanks, payment service providers. Consumer banking services are named in Article 2.

Documents: account statements and fee schedules, terms and conditions, mortgage documentation, KIDs and KIIDs (PRIIPs/UCITS), prospectuses and fund fact sheets, payment account information documents under the Payment Accounts Directive, in-app PDFs.

Sector specifics: beyond Reflow, financial templates fail 1.4.3 (grey body text below 4.5:1) and 1.3.1 (scanned or untagged legacy statements). KIDs and KIIDs are short, structured and numerous — a fund house with 200 share classes automates them via API. Statements come out of core banking systems, so the durable fix is generating the accessible output in the same batch job rather than converting afterwards. T&Cs and product sheets change rarely: convert once per version.

Insurance

Documents: policy documents and certificates of coverage, product information documents (PIDs) under the Insurance Distribution Directive, KIDs under PRIIPs for investment-based products, claims forms, renewal notices and endorsements, annual statements for life and pension customers, terms and conditions.

Sector specifics: KID and PID layouts are mandated by PRIIPs and IDD, so the compliant-format PDF stays and an accessible EPUB3 goes beside it; have compliance confirm the pairing. Risk ratings must not rely on colour alone (1.4.1); claims forms need labelled fields (4.1.2) and a logical focus order (2.4.3). For genuinely simple single-column notices, an Article 14 disproportionate-burden assessment may be arguable — document it and take legal advice. Practical order: week one, inventory and run a PAC 2024 sample; week two, convert the highest-volume certificates and renewals and flag regulated KIDs/PIDs for review; weeks three and four, publish both formats from the portal and file the ACE reports.

Retail

Documents: product manuals and instruction guides, terms and conditions, warranty documents, catalogues and promotional material, returns and complaints procedures, care and sustainability documents increasingly delivered digitally.

Sector specifics: electronics and appliance brands carry the heaviest manual burden; fashion retailers are picking up digital care and sustainability documents. Retailers distributing third-party manuals should review supplier documents for scope rather than assume the manufacturer has done it. Audit the site for linked PDFs this week, convert manuals, T&Cs and warranties, publish the EPUB3 beside each PDF, then add an accessibility check to the document production workflow so new documents ship accessible from the start. Consumer complaints trigger investigations; do not wait for a regulator.

E-commerce

Documents: downloadable product catalogues, user manuals and installation guides, terms and conditions, return and refund policies, warranty documents, invoice templates offered for download.

Sector specifics: e-commerce is named in Article 2, and online stores tend to fix the storefront (contrast, keyboard, ARIA) while the PDFs linked from product pages remain untouched. Split the inventory in two: simple single-column documents (T&Cs, invoices) can be remediated in Acrobat; designed catalogues and manuals built in InDesign fail Reflow whatever the tagging and should be converted. Catalogue product photos need alt text either way. Update the product-page links to point at the accessible versions and attach the ACE reports to the compliance file. Seasonal catalogue refreshes belong in an API workflow.

Transport Operators

In scope: Article 2 names air, bus, rail and waterborne passenger transport services and the documents that support them.

Documents: ticket terms and conditions, timetables, booking confirmations (departure times, seat allocations, assistance arrangements), accessibility service guides describing boarding assistance and how to request it, delay and disruption communications setting out passenger rights and compensation, safety briefing cards and emergency procedures delivered by QR code.

Sector specifics: timetables are dense multi-column tables with compact type, the layout category PDF handles worst; converted to EPUB3 they render as semantic tables in a single column. Booking confirmations are automated, so generate the accessible copy in the same job. Seasonal timetables and policy documents recur, so build conversion into production rather than treating it as one-off remediation. Test with NVDA, VoiceOver and TalkBack before publishing, and keep assessment, conversion and testing records: regulators expect systematic evidence, not assertions.

Higher Education

In scope: public universities have been under the Web Accessibility Directive (2016/2102) for websites and apps since 2018. The EAA adds obligations where an institution acts commercially: tuition-charging programmes, sold course materials, continuing education, open-access publishing platforms. Admission, enrolment and progression documents provided to the public sit squarely inside.

Documents: course handouts and lecture slides published as PDF, reading lists, student handbooks, programme specifications and assessment briefs; regulations, codes of conduct, complaints procedures, data protection notices, financial aid guidance; prospectuses, application guidance, scholarship criteria, disability disclosure forms; research publications and theses in open-access repositories.

Sector specifics: triage by audience and reach, separating born-digital PDFs from scanned ones (scans need OCR before conversion). Convert priority documents, run ACE, fix flagged alt text and heading gaps, then replace the repository copy and log the conversion date and report reference for each item. US public universities face the parallel ADA Title II deadline; see Section 508 and ADA Title II.

Legal: Law Firms, Legal Publishers and Courts

In scope: consumer-facing law firms and legal service providers; legal publishers distributing practice guides, case reporters, statutory compilations and regulatory guidance; in-house legal functions publishing policies and contracts for staff or customers; legal technology platforms delivering documents to EU users. Courts and public legal bodies fall under Directive 2016/2102 and EN 301 549 clause 10 for judgments and procedural guides.

Documents: client care and engagement letters, terms of business, privacy notices, consumer legal information, standard-form contracts offered for download, KYC guides, FAQs, the firm’s own accessibility policy and complaints procedure; for publishers, two-column practice texts with marginal citations, complex tables of contents and cross-referenced footnotes.

Sector specifics: an executed contract is the legal instrument and cannot be swapped for another format. The EAA does not ask for that; it asks that the information be accessible. Keep the signed PDF as authoritative and provide an EPUB3 reading copy with identical content. Clause hierarchies (1 → 1.1 → 1.1.1) become nested lists, definition tables keep their headers, cross-references become links. Firms on iManage, NetDocuments or SharePoint can generate the EPUB3 at the publication step without changing the PDF workflow. UK note: the EAA does not apply directly post-Brexit, but the Equality Act 2010 requires accessible formats as a reasonable adjustment, the SRA expects it, and EU clients or offices bring EAA exposure for that part of the practice.

Publishers and Academic Publishers

In scope: e-books are a named EAA product; any publisher selling digital publications to EU customers is covered regardless of country. For medical, legal and academic publishers, journal articles, clinical guidelines and reference works distributed digitally to EU professionals count too.

What the EAA asks of a publication: reflowable text, programmatically determinable reading order, a navigable table of contents and headings, declared language, alt text on informative images, marked-up table headers. Fixed-coordinate PDF fails the first three by construction; the EU’s own guidance points to EPUB3 as the reference format for accessible digital publications.

Sector specifics: backlists run to millions of two-column PDFs, and a PDF/UA-compliant article still fails Reflow, so per-document specialist remediation cannot close the gap at any budget. Publishers with JATS XML sources should go JATS to EPUB3 directly; PDF-only backlist (most pre-2010 content) is converted. Validate with ACE by DAISY aiming for zero critical errors, spot-check with NVDA and Firefox or VoiceOver, declare accessibility conformance in product metadata (EPUB Accessibility 1.1), and for new titles export EPUB3 first from InDesign, Word or LaTeX with PDF as the print derivative.

Nonprofits and NGOs

In scope: EU-based foundations and nonprofits, international NGOs serving EU constituencies, trade associations and professional bodies with EU members, cultural organisations (museums, archives, libraries). UK charities are covered by UK accessibility regulations and the Equality Act 2010 instead. Most established nonprofits exceed the microenterprise thresholds.

Documents: annual reports and financial statements, policy papers and research publications, grant application guides and forms, membership registration forms, event programmes and conference materials. The test is whether someone uses the document to access your services.

Sector specifics: volumes are small — one annual report, a few dozen papers and programmes a year — so the cost barrier is close to zero. Prioritise documents in active service use (grant guides, registration forms, the current annual report), then high-download items from the last two or three years, then archive material, for which a statement that accessible versions are available on request may suffice. The ACE report answers a donor or regulator asking for evidence.

The Compliance Path Shared by Every Sector

Keep producing PDF as the print, archival or regulatory format; no workflow change.
Convert each document to EPUB3 for digital distribution at toolkit.bot/pdf2epub; bulk and system-generated documents go through the API.
Publish both: PDF download and EPUB3 download, labelled.
Validate the EPUB3 with ACE by DAISY and keep the report as compliance documentation.

toolkit.bot reconstructs reading order across columns, preserves tables with header markup (dosing charts, timetables, definition tables), maps section hierarchies to semantic headings, and keeps regulator-mandated section order intact. Figures without an embedded description in the source PDF are the usual remaining ACE finding; add alt text in an EPUB editor for priority documents.

npm install -g @daisy/ace
ace --outdir ./compliance-report ./document.epub

Convert a leaflet, statement, timetable or contract PDF — free, no account required.

Convert PDF to EPUB3 → API for catalogue-scale conversion

Frequently Asked Questions

Does the European Accessibility Act apply to pharmaceutical companies?

Yes. Pharmaceutical companies distributing patient information leaflets, SmPCs, risk minimisation materials and corporate publications to EU consumers or investors are in scope. EMA’s QRD templates fix the PDF layout, so EMA guidance recommends providing an accessible alternative format alongside the required PDF; EPUB3 fills that role.

Do hospitals need to make patient documents accessible under the EAA?

Yes. Discharge summaries, outpatient letters, clinical trial recruitment materials and hospital guides distributed digitally to EU patients as part of a health service are in scope, and the patients receiving them are disproportionately likely to have low vision.

Are universities, law firms and nonprofits exempt?

No. The only size-based exemption is for microenterprises with fewer than 10 employees and turnover or balance sheet not exceeding €2 million, and it applies to services only. Public universities and courts fall under the Web Accessibility Directive (2016/2102) instead of the EAA; the obligation is equivalent.

What about documents whose format is mandated by another regulation, such as KIDs, PIDs or PILs?

Keep the compliant-format PDF and publish an accessible EPUB3 with the same content alongside it. The EAA requires the information to be accessible; it does not require altering a regulated layout or a signed legal instrument.

Why can’t PDF remediation solve WCAG 1.4.10 Reflow?

PDF is a fixed-layout format. A two-column A4 document at 400% zoom needs horizontal scrolling on every line. Acrobat Pro, CommonLook and axesPDF fix tags, reading order and alt text but cannot change page geometry. EPUB3 is built on HTML5 and reflows to any viewport width by design.

Related Guides

Whatever the sector, WCAG 1.4.10 Reflow is the gap tagged PDF cannot close, and the readers most affected are the ones your documents exist to serve.