Digital vs. Print Manuals

New EU rules just dropped for digital instructions for use (IFUs) — here's what you actually need to know... In plain English. The European Commission quietly updated its eIFU regulation this week: Commission Implementing Regulation (EU) 2025/1234 It’s an update to the 2021 rules on when medical device instructions for use can be provided digitally instead of in paper form. 💡 Here’s the plain English version — not just for Regulatory Affairs, but for Product, QA, Clinical, and anyone else working with devices: ✅ What’s changed? More devices now qualify for digital-only IFUs, including: - ALL professional-use medical devices - Devices still on the market via MDD transitional provisions - Non-medical devices like aesthetic lasers and liposuction equipment (if for professional use) But if there's any realistic chance a layperson (like a patient) might use it → you still need paper. This safeguard stays in place. Manufacturers will need to register the online IFU link in EUDAMED once device registration becomes mandatory — making digital access traceable and auditable. Some unclear or redundant requirements were cleaned up or deleted, especially those already covered under MDR’s conformity assessment. Why this matters (beyond RA/QA) This isn’t just regulatory noise for the fun of it. This shift affects: 📦 Packaging & supply chain: fewer printed booklets = lower costs 🌱 Sustainability goals: less paper waste 🔄 Faster IFU updates when software or workflows change 📲 User experience: eIFUs must be easy to find and navigate 📣 Labeling, marketing, clinical support: all need to align And for devices used in mixed settings (e.g. clinics + home), this forces a real conversation: Who is the real end user — and how do we support them? 📍 Bottom line: The EU is steadily building a more digital, traceable, and user-friendly ecosystem for medical devices — and this is one more piece of that puzzle. #MedTech #MedicalDevices #eIFU #EURegulations #DigitalHealth #MDR #RAQA

Comparison of Paper Tech Log vs. E-Tech Log 1. Paper Tech Log A traditional aircraft technical logbook (tech log) is a physical document where pilots and engineers record aircraft maintenance status, defects, and rectifications. Benefits: • Simplicity: No need for electronic devices or internet access. • Familiarity: Most engineers and pilots are trained to use it. • No System Failures: Not affected by software bugs, crashes, or data corruption. • Legal Acceptance: Well-established in aviation regulations and easy to verify. Disadvantages: • Prone to Damage or Loss: Can be misplaced, torn, or damaged. • Manual Data Entry: Requires handwriting, which can lead to readability issues and errors. • Time-Consuming: Slower to fill out and review, leading to delays. • Storage Issues: Requires physical space for archiving and can be hard to retrieve past records. ⸻ 2. E-Tech Log An electronic technical log (e-tech log) is a digital system that records maintenance activities and aircraft status electronically. Benefits: • Accuracy & Readability: Eliminates handwriting issues and reduces human errors. • Real-Time Updates: Maintenance and operations teams can access data instantly. • Data Storage & Retrieval: Easy to search, retrieve, and analyze historical data. • Integration: Can be linked to airline maintenance systems, reducing paperwork and improving workflow. • Security & Compliance: Reduces risk of lost or falsified records and enhances regulatory compliance. Disadvantages: • System Dependency: Requires software, hardware, and internet access. • Training Required: Users need training to use the system effectively. • Technical Issues: Vulnerable to software failures, hacking, or system crashes. • Cost: High initial investment in software, hardware, and maintenance. ⸻ Conclusion • Paper Tech Logs are reliable, simple, and widely accepted but come with issues like storage, legibility, and manual errors. • E-Tech Logs improve efficiency, accuracy, and accessibility but require investment in technology and infrastructure. Many airlines are transitioning to e-tech logs due to operational and regulatory advantages, but some still maintain paper tech logs as a backup.

No one prints out manuals thinking 'this will cost us thousands' But over time? Paper printing, hours of editing and storage. Training time to explain what’s on page 47... (and how's that different from page 48) Mistakes because someone read the old version. It all adds up. I've met OEMs who spend hundreds of thousands just keeping technical documentation alive — and still get technician errors and repair delays. The switch to digital, animated work instructions isn’t just about being modern. It’s margin protection 🛡️ --- #Aftersales #OEMAftersales #SpareParts #WorkInstructions