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Medical Device IFU Accessibility: EU MDR, IVDR, and the EAA

The Compliance Intersection: EU MDR, IVDR, and EAA

Medical device manufacturers distributing Instructions for Use (IFU) digitally face a convergence of accessibility requirements in 2026 that is not yet widely understood in the industry.

EU MDR (2017/745) and IVDR (2017/746): Require that IFUs are available in human-readable form and, where provided electronically, in accessible formats as required by national legislation. The 2021 Commission implementing regulation on electronic IFUs (EU 207/2012) permits electronic IFU distribution under specific conditions, including accessibility.

EAA (Directive 2019/882), enforcement active June 28, 2026: Sets WCAG 2.1 AA as the technical standard for digital content provided to consumers. Medical devices sold commercially to EU consumers fall within the scope of EAA product requirements for accompanying documentation.

The result: Digital IFUs distributed to patients and end users must satisfy WCAG 2.1 AA — including WCAG 1.4.10 Reflow. And fixed-layout PDF cannot satisfy that criterion.

What the Problem Looks Like

An IFU for a blood glucose monitor, a CPAP device, or a home defibrillator typically runs to 40–80 pages. Standard IFU layout includes:

This layout — mandatory under EU MDR Annex I Section 23, which requires IFUs to contain specified information in a usable format — is exactly the type of content that fails WCAG 1.4.10 in PDF.

At 400% zoom (standard assistive zoom for users with low vision), a two-column IFU PDF scales to approximately 3,200px wide. The user must scroll horizontally to read each line of each column. That is the Reflow failure.

Why PDF Remediation Does Not Fix This

IFU accessibility is already an area of activity — accessibility tagging under PDF/UA (ISO 14289) is required by some notified body audits for Class IIb and III devices. But PDF/UA tagging does not fix WCAG 1.4.10:

Acrobat Pro, CommonLook, and axesPDF all produce PDF/UA-compliant output. None produces a document that satisfies WCAG 1.4.10 for complex multi-column layouts. This is a documented limitation of the PDF format, not a tool deficiency.

EPUB3: The Accessible IFU Format

EPUB3 satisfies WCAG 1.4.10 structurally. Built on HTML5 and CSS, content flows to the available viewport width at any zoom level. For a user with low vision:

For patients who use medical devices — particularly elderly patients and those with chronic conditions who may have low vision or use assistive technology — reflowable EPUB3 IFU is demonstrably more usable than fixed-layout PDF.

The Regulatory Stack for Digital IFU

Requirement Framework Standard
IFU must be provided in accessible format EU MDR Art. 10(11) / IVDR Art. 10(10) As required by national legislation
Digital IFU distribution requirements Commission Implementing Regulation (EU) 207/2012 Electronic IFU conditions
Digital accessibility technical standard EAA (Directive 2019/882) WCAG 2.1 AA
Non-web document accessibility EN 301 549 Clause 10 WCAG 1.4.10 Reflow
Accessible format for digital IFU WCAG 2.1 + EPUB Accessibility 1.1 EPUB3

Practical Implementation

Option 1: Dual-format distribution (recommended)

Keep the PDF for: print reproduction in packaging, notified body submission, regulatory filing.
Provide EPUB3 for: digital distribution on device website, QR code download, manufacturer’s patient portal.

Clearly label both:

[Download IFU (PDF, print version)]
[Download IFU — Accessible EPUB3 format (WCAG 2.1 AA)]

Option 2: API-integrated IFU generation

For manufacturers producing IFUs programmatically (localised versions for each EU member state), integrate toolkit.bot at the IFU generation step:

import httpx

def generate_accessible_ifu(pdf_bytes: bytes, product_ref: str, language: str) -> bytes:
    """Generate EPUB3 IFU alongside PDF for each product/language combination."""
    resp = httpx.post(
        "https://toolkit.bot/api/convert",
        headers={"Authorization": f"Bearer {API_KEY}"},
        files={"file": (f"ifu_{product_ref}_{language}.pdf", pdf_bytes, "application/pdf")},
        timeout=120
    )
    resp.raise_for_status()
    return resp.content  # EPUB3 binary

A Class IIa device with 27 EU language versions produces 27 IFU PDFs per product update. At API pricing ($29/month, 100 requests/hour), the full conversion of all language versions runs in under 20 minutes.

Validation and Documentation

Each EPUB3 IFU should be validated with ACE by DAISY:

npm install -g @daisy/ace
ace --outdir ./ifu-ace-report ./ifu_product_en.epub

The ACE report:

This documentation supports:

Priority IFU Categories

Highest priority (convert now):

High priority:

Standard priority:

Notified Body and EAA Enforcement Notes

EAA enforcement in the medical device sector overlaps with MDR/IVDR post-market surveillance. National market surveillance authorities (BSI in UK, BfArM in Germany, ANSM in France) are already familiar with IFU compliance reviews. EAA enforcement by the same or adjacent national authorities creates compounding risk for non-compliant digital IFU distribution.

Providing EPUB3 alongside PDF — with ACE validation documentation — is the cleanest path to satisfying both sets of requirements before a complaint is filed.

Convert an IFU PDF — free, no account required.

Convert PDF to EPUB3 →   API for batch IFU conversion

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