The European Commission has just expanded the scope of electronic instructions for medical devices—applying to nearly all professional-use products. If your IFU process isn't digital-ready, you may lose EU market access.
From July 2025, digital instructions will become the new default for professional-use medical devices in the EU. If you're still relying on paper documentation, your compliance strategy may already be outdated.
What just changed—and why it matters
The paper era is ending. Your IFU strategy must evolve.
Commission Implementing Regulation (EU) 2025/1234, published on 25 June 2025, fundamentally expands electronic instructions for use (eIFU) requirements under the EU Medical Device Regulation. This isn't just a rule change—it's a shift in how the EU expects devices to communicate risk and safety.
The strategic context: This change mirrors the FDA's growing reliance on digital IFUs, though the EU remains more cautious with layperson protection. The dual-format requirement reflects MDR Annex I's user safety principles—and signals where regulators may crack down on borderline devices.
Why now? A Commission survey from August to October 2024 showed healthcare professionals overwhelmingly prefer electronic instructions, with digital formats helping the health sector deliver better and faster solutions.
Who's covered
Device Category
Previous Status
New Status
Impact
All professional medical devices
Limited categories only
✅ All covered
Major expansion
Medical device accessories
Limited categories only
✅ All covered
Significant change
Annex XVI devices (cosmetic contact lenses)
Not covered
✅ Now covered
New requirement
Article 120 transitional devices
Not covered
✅ Now covered
Compliance catch-up needed
Fixed installation devices
Limited coverage
✅ Full coverage
Infrastructure updates required
What's exempt
❌ Devices intended solely for lay users (consumers/patients)
Lay user exception
⚠️ Key Risk: If both professionals and laypeople might use your device, paper instructions remain mandatory for lay users. Missing this may lead to market access issues.
SMEs with legacy labelling systems face the biggest operational challenge. For established manufacturers with cross-border distribution models, managing website accessibility requirements across multiple markets creates new complexity layers.
What you must do
📌 Portfolio audit: Review your current product portfolio to identify which devices are now covered under the expanded scope
📌 Format assessment: Assess your existing instruction formats and determine which products currently provide paper instructions to professional users that could transition to electronic format
📌 Dual-format mapping: Identify devices that both professionals might use and lay persons
📌 Website compliance: Establish a robust website infrastructure to host electronic instructions with proper version control and accessibility features
📌 Version management: Develop systems to manage dual-format requirements where your professional-use devices might also be used by patients or lay persons
📌 Obsolescence planning: Ensure instructions remain accessible even when devices become obsolete
Database integration (By UDI Registration Deadlines)
📌 Eudamed connectivity: Prepare to provide internet addresses for electronic instructions to the Eudamed UDI database
📌 Article 123(3) compliance: Under MDR Article 123(3)(d), UDI data must include "a means to access electronic instructions" where applicable
Where compliance will be tricky
Dual-format challenges
The regulation requires explicit paper instructions for lay users, meaning that some products will need to be available in both formats. Healthcare institutions may use "professional" devices in patient-facing scenarios, creating compliance grey areas.
Website requirements
Version control systems for all issued electronic versions
Publication date tracking
Obsolete version access upon request
Specific technical accessibility standards
Integration capability with Eudamed platform
UDI integration complications
Your electronic instruction systems must integrate seamlessly with Eudamed requirements. Many legacy manufacturers lack the technical infrastructure for this integration.
This is the beginning of complete MDR digitalisation
This isn't the end of the transformation—it's the acceleration phase. Early adopters gain competitive advantage whilst late movers face compliance scrambles and potential market access delays.
What's coming next:
Digital Product Passport integration: DPP requirements will likely follow similar expansion patterns
Harmonisation trends: National competent authorities are aligning on digital-first approaches
Eudamed evolution: The database will become increasingly central to market surveillance
Your compliance roadmap:
✅ For established manufacturers
Infrastructure first—ensure your IT systems can handle version control and database integration before transitioning individual products.
Complete portfolio mapping and technical architecture planning.
Complete website infrastructure deployment with Eudamed integration capability.
✅ For SMEs
Consider partnering with regulatory consultants for technical implementation and guidance. The complexity of dual-format management and Eudamed integration may exceed internal capabilities.
Focus on the highest-volume products first to minimise market access disruption.
✅ For cross-border distributors
Ensure manufacturer partnerships include digital-ready IFU processes that won't create downstream compliance gaps.
Plan for varying interpretations from national competent authorities during the transition period.
What comes next
Expect further digitalisation announcements around:
Harmonised standards for electronic instruction accessibility
Post-market surveillance integration with digital IFU tracking
AI-driven translation requirements for multi-language markets
The EU has clearly signalled its commitment to digitalisation in medical device regulation. This change reflects broader regulatory momentum towards digital-first compliance across multiple sectors.
Bottom line: Don't wait for your competitors to gain a digital advantage. Begin compliance preparations now to ensure seamless market access across all EU member states.
Ready to navigate these digital requirements? Need help updating your eIFU documentation and website for Eudamed? Our MDR specialists can help map the full risk of your portfolio.
👉 Schedule a 20-minute consultation with one of our compliance experts today.
