Switzerland aligns with the EU on new eIFUs regulation

In August 2025, Swissmedic announced to adopt the new EU requirements on eIFUs with immediate effect. With this alignment, it is possible to use electronic instructions for use (eIFUs) for all medical devices for professional use. More specifically, the scope is extended to all medical devices and their accessories as well as to products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (EU MDR) and legacy device.

Use of electronic IFUs in the EU and Switzerland

In June, the European Commission released Commission Implementing Regulation (EU) 2025/1234, an update to Regulation (EU) 2021/2226 about electronic instructions for use (eIFUs) of medical devices on the Union market.

Additionally, manufacturers selling medical devices in Switzerland and the EU must take into account the following:

• IFUs of devices intended for use by lay persons shall continue to be provided in paper form.
• UDI registration on EUDAMED (device registration) shall come with internet address under which the electronic instructions for use are accessible.

Commission Implementing Regulations (EU) 2021/2226 and 2025/1234 apply in Switzerland directly and without additional amendments to MedDO, the Swiss Medical Devices Ordinance.

For more information, contact MDlaw Team here or at mdlaw@obelis.net.

References:

Swissmedic (2025). Implementation in Switzerland of EU Commission Implementing Regulation on instructions for use in electronic form. Retrieved on 25/08/2025.