Switzerland adopts EU rules on electronic instructions for use for medical devices
On 8 August 2025, Swissmedic announced the immediate implementation of Commission Implementing Regulation (EU) 2025/1234 on electronic instructions for use (e-IFUs). The measure aligns Switzerland with the latest EU requirements and extends the permitted scope for e-IFUs when devices are intended for professional users.
Overview of the new EU provisions
On 25 June 2025, the European Commission adopted Regulation (EU) 2025/1234, which amends Implementing Regulation (EU) 2021/2226. The amendment entered into force on 16 July 2025 and broadens the types of devices for which instructions may be provided electronically.
When devices are intended for professional users, the updated rules now permit e-IFUs for:
- all medical devices and their accessories;
- products without an intended medical purpose listed in Annex XVI to the EU MDR;
- legacy devices previously covered under older transitional rules.
Instructions for use intended for lay persons must still be supplied in paper form. In addition, manufacturers registering devices must provide Eudamed’s UDI database with the internet address where the e-IFU is hosted.
Repeal of the previous framework
Regulation (EU) 2025/1234 repeals Regulation (EU) 207/2012, which had governed electronic instructions for a subset of legacy devices. With the repeal, the updated implementing regulation now provides a single, broader framework for e-IFUs under the MDR.
How the change applies in Switzerland
Previously, Switzerland referenced Regulation (EU) 207/2012 via Annex 3 number 1.2 of the Medical Devices Ordinance (MedDO, SR 812.213). Article 95(2) MedDO stipulated continued application of that EU regulation until a new Implementing Regulation was adopted.
Swissmedic applies EU Commission Implementing Regulations directly under Article 95(1) MedDO. As a result, both Implementing Regulation (EU) 2021/2226 and the amended Regulation (EU) 2025/1234 now apply in Switzerland immediately and without further amendment to the MedDO.
Impact on manufacturers
The adoption of Regulation (EU) 2025/1234 in Switzerland introduces several practical implications for manufacturers:
1. Broader use of e-IFUs for professional users
Manufacturers may now provide instructions exclusively in electronic form for all devices intended for professionals, including accessories and Annex XVI products. This change can reduce printing costs and support sustainability initiatives.
2. Mandatory registration of the e-IFU address
Companies must submit to Eudamed’s UDI database the stable internet address where the e-IFU is accessible. Ensuring uptime, security and version control for that hosting location becomes a regulatory requirement.
3. Clear user segmentation and labelling
Because e-IFUs are permitted only for professional users, manufacturers must implement reliable mechanisms to distinguish professional from lay-user channels. Labelling, sales channels and packaging should clearly indicate when a device requires a paper IFU for lay users.
4. Operational and technical responsibilities
Manufacturers need robust technical and operational processes to guarantee continuous access to e-IFUs, including:
- redundant hosting and monitoring;
- access control where required (e.g., professional portals);
- document versioning and audit trails;
- data protection and cybersecurity measures for hosted content.
5. Harmonised compliance across EU and Switzerland
Alignment with EU rules simplifies cross-border regulatory strategies. Companies that already follow the EU provisions will find compliance in Switzerland more straightforward, reducing administrative overhead for market access.
What stakeholders should do next
Manufacturers and authorised representatives should review their IFU distribution practices and hosting arrangements. Specifically, they should:
- identify devices intended for professional users and confirm eligibility for e-IFUs;
- register the e-IFU internet address in Eudamed’s UDI database as required;
- ensure clear labelling and instructions for lay users who must still receive paper IFUs;
- implement technical measures for reliable access, version control and security;
- update internal procedures and quality documentation to reflect the new obligations.
Conclusion
Swissmedic’s adoption of Implementing Regulation (EU) 2025/1234 brings Switzerland into line with the EU on the electronic provision of instructions for use. The change widens the scope for e-IFUs intended for professional users and clarifies obligations for manufacturers. It also underscores the growing importance of resilient digital infrastructure and clear user segmentation in regulatory compliance.
Reference and call to action
For full details, consult Swissmedic’s official communication on the implementation of Regulation (EU) 2025/1234 and the text of the implementing regulation. If you would like, we can help prepare a compliance checklist or a draft update to your technical documentation and hosting policy.
