New EU Regulation on eIFUs Adopted by Swissmedic 

Swissmedic has adopted EU Commission Implementing Regulation (EU) 2025/1234, which extends the scope of electronic instructions for use (eIFUs) for medical devices. The regulation came into force in the EU on 16 July 2025 and was adopted by Swissmedic on 8 August 2025. For more information on the EU regulation, review our previous blog here.  

Key Highlights:  

• eIFUs are now permitted for all medical devices and accessories, including products without a medical purpose listed in Annex XVI of EU MDR and legacy devices, provided they are intended for professional users only. 

• Devices intended for laypersons must still include paper instructions. 

• Manufacturers must register the internet address (URL) where the eIFU is accessible in EUDAMED’s Unique Device Identifier (UDI) database. This ensures traceability and accessibility of digital documentation. 

Regulatory Changes: 

• Repeal of Regulation (EU) 207/2012: This older regulation has been repealed and replaced by the new 2025/1234 regulation. 

• Swiss Implementation: Switzerland directly applies EU Implementing Regulations 2021/2226 and 2025/1234 without needing to amend its own Medical Devices Ordinance (MedDO). 

Compliance and Market Access 

• Manufacturers must ensure that their devices meet the updated eIFU criteria to maintain market access in Switzerland. 

• Devices placed on the Swiss market must comply with Swissmedic’s surveillance and registration requirements, including: 
  • Appointing a CH-REP (Swiss Authorized Representative) if not based in Switzerland 
  • Registering with Swissmedic 
  • Reporting serious incidents 
  • Ensuring translation and repackaging of product information where applicable (i.e. labeling in the 3 mandatory languages German, French and Italian ) 

Strategic Considerations 

• Manufacturers may benefit from cost savings and sustainability by transitioning to eIFU for professional-use devices. 

• However, they must maintain dual formats (electronic and paper) for devices used by laypersons.

How MedEnvoy Can Support 

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