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.

The session

Structured in two parts

Part 1 — Regulatory

Kirsten Van Garsse

Business Unit Manager RA IVD, QbD Group

Profile

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

Eline Heylen

Senior Consultant eIFU, IFUcare, QbD Group

Profile

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.