---
title: "Expanded eIFU Eligibility under EU Regulation 2025/1234"
description: "Learn how Commission Implementing Regulation (EU) 2025/1234 broadens electronic Instructions for Use (eIFUs) for professional medical devices, the compliance steps required, and how IFUcare can help."
url: https://qbdgroup.com/zh-cn/regulatory-updates/expanded-eifu-eligibility-under-eu-regulation-2025-1234
type: "Regulatory update"
language: zh-cn
published: 2025-07-03
author: "QbD Group, Regulatory Affairs"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"Expanded eIFU Eligibility under EU Regulation 2025/1234\", https://qbdgroup.com/zh-cn/regulatory-updates/expanded-eifu-eligibility-under-eu-regulation-2025-1234"
---
# Expanded eIFU Eligibility under EU Regulation 2025/1234
> Learn how Commission Implementing Regulation (EU) 2025/1234 broadens electronic Instructions for Use (eIFUs) for professional medical devices, the compliance steps required, and how IFUcare can help.

## Expanded rules for electronic instructions for use (eIFUs)

**Effective**: Published June 27th, entering into force 20 days later

**Amends**: Commission Implementing Regulation (EU) 2025/1234

**Purpose**: To broaden the scope of devices eligible to provide IFUs in electronic form instead of paper.

## What changed?

The EU now allows **all medical devices and their accessories intended for professional users** to provide electronic Instructions for Use (eIFUs). This means the scope is no longer limited to devices like (active) implantables, fixed installed medical devices, and devices with a built-in system for visually displaying instructions. This change responds to industry demand and digital transformation trends.

[![Take the eIFU readiness test](https://no-cache.hubspot.com/cta/default/7030766/interactive-192139749152.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLKVhQ7RFOwBT%2BW8ftQl9XRiw8K68HMQa1efHG%2F5z58kjiu8n8aNGbceaBoesVmztLtl04C66EamQNtvVSLezOw8pIWJrK2IIliB2yucCGV%2FXOPUA8g4BuM%2Fa9i5L5AoCLuTTNkVgJRuQj%2FILrtm2rbS1pyh7N3GlDBhZpDEnh8FcoRjOAQTcGJcMw6e0wBJN8c%3D&webInteractiveContentId=192139749152&portalId=7030766)
Below you’ll find the key highlights of the regulation, or you can consult the **[document of the Official Journal of the European Union](https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501234).**

## Key highlights

### 1\. Wider scope of eligibility

- All devices and their accessories intended for professional use are now eligible
- Applies even to devices without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
- Devices under transitional MDR provisions are included
- If lay persons are likely users, a paper IFU is still required for them

### 2\. Compliance requirements remain strict

- A documented risk assessment is still mandatory
- Manufacturers must ensure:
  - Secure and user-friendly access to eIFUs
  - Backup and emergency protocols
  - Website uptime and data protection (GDPR)
    - Paper IFUs must be available on request, within 7 days

### 3\. Labeling and website requirements

- Product labels must indicate eIFUs are provided
- Website must host current IFU and historical versions must be at least made available on request
- eIFUs must be accessible in official EU languages, as applicable
- From the moment registration in EUDAMED becomes mandatory, internet access URLs must be registered

## How you can take advantage of the updated regulation

You can now:

- **Replace printed IFUs** for a much wider range of devices
- **Digitize documentation workflows**, reducing costs
- **Improve update speed** and support sustainability goals. But you must still meet strict EU MDR/IVDR requirements regarding the IFU for content, delivery, labeling, and traceability.

### Your partner in eIFU compliance

**Commission Implementing Regulation (EU) 2025/1234 opens the door much wider** for manufacturers to adopt electronic IFUs but it also reinforces the need for **controlled access, version tracking, and alignment with EUDAMED**.

[IFUcare can support full eIFU compliance.](https://ifucare.io/) Our platform offers:

- **Commonly used formats**: we provide eIFUs in widely accepted formats that can be read with freely available software.
- **Security**: robust protection against hardware and software intrusions to safeguard your information.
- **Minimal downtime**: our platform is designed to reduce server downtime and display errors, ensuring that your eIFUs are always available.
- **Multilingual support**: clear indication of the languages in which the eIFUs are provided.
- **Stable internet address**: guaranteed stable and accessible internet address for your eIFUs, in compliance with regulatory requirements.
- **Version control**: access to all previous versions of your eIFUs and their publication dates.

[![Visit website](https://no-cache.hubspot.com/cta/default/7030766/interactive-192177182871.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLKr39gdgBvzvVZ9TM3NCjEbzNuIGRBg8aZXOwwjfDREqLKLF5LPsX5qchbW3qtBiTTUpAwh7usv1DVQH2qzO9l5%2FPSQqWsMLXQTZOd21KPegmKvvMeNFTMSvW38sobPc%2BNFbjGiLzsBqmTzgh85P3MPoUeYFYY%3D&webInteractiveContentId=192177182871&portalId=7030766)
[![Take the eIFU readiness test](https://no-cache.hubspot.com/cta/default/7030766/interactive-192139749152.png)](https://qbdgroup.com/hs/cta/wi/redirect?encryptedPayload=AVxigLKVhQ7RFOwBT%2BW8ftQl9XRiw8K68HMQa1efHG%2F5z58kjiu8n8aNGbceaBoesVmztLtl04C66EamQNtvVSLezOw8pIWJrK2IIliB2yucCGV%2FXOPUA8g4BuM%2Fa9i5L5AoCLuTTNkVgJRuQj%2FILrtm2rbS1pyh7N3GlDBhZpDEnh8FcoRjOAQTcGJcMw6e0wBJN8c%3D&webInteractiveContentId=192139749152&portalId=7030766)
---
Source: https://qbdgroup.com/zh-cn/regulatory-updates/expanded-eifu-eligibility-under-eu-regulation-2025-1234 — © QbD Group. Quote freely with attribution and a link back.