EU Expands eIFU for Medical Devices

On 25 June 2025, the European Commission published Implementing Regulation (EU) 2025/1234, which amends Implementing Regulation (EU) 2021/2226, clarifying when instructions for use (IFUs) for medical devices may be provided in electronic form (eIFUs) across the EU. The regulation is not yet in force but is slated to go into effect on 16 July 2025.

The amendment seeks to enhance accessibility, minimize dependence on paper, and simplify processes for manufacturers and users, while supporting the EU’s digital transformation objectives in medical technologies.

Key Highlights

• Scope is extended to include medical device accessories (Article 2) and applies to all devices intended for professional use (Article 3). 
• Devices for both professional and lay use still require an IFU in paper form (Article 3). 
• All versions of the eIFUs shall be made available upon request (Article 5). 
• Manufacturers must link eIFUs to EUDAMED’s UDI database (Article 7). 
• Notified Body review is no longer specifically outlined in the updated regulation (removal of Article 8). 

Impact on Manufacturers When Placing Devices in Other Markets

Great Britain (England, Scotland, Wales)

• Great Britain left the EU and does not automatically adopt new EU regulations such as EU 2025/1234.
• UK retained the 2002 Medical Devices Regulations, which reference earlier EU legislation. In May 2025, the MHRA formally removed revocation dates for several EU-derived laws, including EU Regulation 207/2012 on eIFUs, keeping them in force for now.
• This means that existing eIFU provisions (from 2012) remain operative in GB until the MHRA updates domestic law. But any new EU changes (e.g., scope extension under 2025/1234) are not yet adopted in GB law.

North Ireland

• NI continues to follow EU MDR/IVDR directly under the Brexit withdrawal agreement’s Northern Ireland Protocol.
• Once EU 2025/1234 enters into force on 16 July 2025, it will automatically apply in Northern Ireland, enabling similar expanded eIFU options for devices marketed there.

Switzerland

Switzerland typically mirrors key EU device regulations to maintain regulatory equivalence and avoid market fragmentation. However, as per Section 1.2 of Annex 3 of the MedDO, Switzerland continues to follow EU Regulation 207/2012 on eIFUs until further notice.

Summary

How MedEnvoy Can Support

MedEnvoy offers expert regulatory support to manufacturers in navigating eIFU requirements and compliance. If you have any questions regarding the above, we encourage you to reach out to our regulatory experts here.