Webinar eIFU in practice: from regulatory requirements to implementation
With Regulation (EU) 2025/1234, electronic Instructions for Use are now permitted for a much wider range of medical devices and IVDs intended for professional use.
For many manufacturers, this opens the door to move away from paper, cut costs, improve version control and customer experience. It also raises a practical question: what does compliant eIFU actually require, and how do you implement it without creating new regulatory risk?
This webinar covers both sides. First, the regulatory picture: why eIFU exists, where it is accepted, whether your product is eligible, and what changes between Medical Devices and IVD. Then the practical side: how a compliant eIFU process works day to day, from validation and version management to handling paper copy requests and meeting local requirements.
What you will learn
Seven things you will take away
- Why eIFU exists and the thinking behind the regulation
- Whether eIFU is accepted in your target regions, and whether your product is eligible
- The key differences between Medical Devices and IVD
- The core requirements: validation, security, local regulations
- How those requirements translate into the software development life cycle (SDLC) behind a validated eIFU system
- How to handle paper copy requests in a compliant way
- How version management and country/region management work in practice
Structured in two parts
Part 1 — Regulatory by Kirsten Van Garsse, Business Unit Manager RA IVD, QbD Group
Why eIFU exists, key considerations to be made before switching to eIFU, the differences between Medical Devices and IVD, and the key requirements every manufacturer needs to meet.
Part 2 — Practical by Eline Heylen, Senior Consultant eIFU, IFUcare, part of QbD Group
How those requirements come together in practice: validation according to the SDLC procedure, paper copy request handling, and how to ensure version and country management of an eIFU.