UX Regulatory Compliance: Why Usability Drives Medtech Certification

UX Regulatory Compliance: A Crucial Trend in the Medical Technology Sector 

Usability is no longer just a design concern – it's a regulatory requirement. Since the introduction of the EU Medical Device Regulation (MDR 2017/745), usability has become a legally defined aspect of product quality. According to Annex I, Chapter 3, Section 23, instructions for use must be “clearly formulated and demonstrably understandable” (source: Custom Medical). This applies not only to manuals but also to user interfaces – especially for medical software. 

In parallel, the international standard IEC 62366 defines a structured usability engineering process. It includes risk analysis, formative testing (early-stage validation), and summative testing (final validation), ensuring that critical use errors are identified and mitigated (source: greenlight.guru, medtechinnovate.io). The FDA follows a similar path and views usability engineering as a prerequisite for safe and effective medical devices (source: uxfirm.com, devicelab.com).

Business Value: 

• Faster approvals: Regulatory compliance with usability engineering shortens time-to-market. 

• Cost savings: Early UX testing prevents expensive redesigns, compliance issues, or recalls. 

• Market readiness: Intuitive and safe products improve adoption, reduce onboarding friction, and limit user error. 

What Compliance Requires – and Why It’s a UX Issue 

🔍 MDR Requirements (EU): 

Usability must be proven. Instructions and software UIs must be easy to understand, with default settings clearly explained. 

→ See: custom-medical.com – MDR and usability 

📊 IEC 62366 Standard: 

Usability must be risk-based. The standard demands structured evaluation with representative users for both early and final stages of development. 

→ See: greenlight.guru – IEC 62366 guide 

→ See: medtechinnovate.io – UX and Human Factors 

The UOUP process (Use of Unknown Provenance) allows re-use of existing UI elements if previously validated – saving time and cost in iterative updates. 

→ See: custom-medical.com – UOUP Process 

🏥 FDA Requirements (USA): 

The FDA requires human factors validation as part of the approval process. In software-based devices, UX plays a key role in risk mitigation and patient safety. 

→ See: devicelab.com – UX and FDA Design 

→ See: uxfirm.com – Medical Device UX Testing 

🚨 Consequences of Non-Compliance: 

• Delayed or denied product approval 

• High risk of product recalls or adverse events 

• Reputational damage and competitive disadvantages 

Which UX Methods Support Compliance? 

The following methods ensure safety, usability, and regulatory fitness: 

• Risk-based usability engineering (IEC 62366) 

• Cognitive walkthroughs and heuristic evaluations 

• Formative and summative usability testing with representative users 

• UOUP assessment to optimize use of existing UI elements 

These techniques support compliance, reduce risks, and provide measurable value for both users and product teams. 

Why uintent Is a Strong Partner for UX Regulatory Compliance 

• Regulatory fluency: We understand MDR, FDA, and IEC 62366 – not just from a design angle, but from a compliance perspective. 

• Embedded UX expertise: Our researchers and strategists can work inside your teams, ensuring compliant design from the outset. 

• Scalable global research: Our international team supports usability testing in line with regional regulatory demands. 

• Process and documentation know-how: We help structure, run, and document usability efforts that are ready for audits and approval processes. 

💌 Not enough? Then read on – in our newsletter. It comes four times a year. Sticks in your mind longer. To subscribe: https://www.uintent.com/newsletter