[2025-08-08] On August 8, 2025, Swissmedic, the Swiss Agency for Therapeutic Products, immediately adopted the new European Union (EU) requirements for the electronic availability of instructions for use for medical devices.
Context
As a reminder, the new Implementing Regulation (EU) 2025/1234, amending Implementing Regulation (EU) 2021/2226, was adopted on June 25, 2025 and came into force on July 16, 2025.
Implementing Regulation (EU) 2025/1234 has significantly extended the scope of Implementing Regulation (EU) 2021/2226 on electronic Instructions for Use (eIFU) for medical devices (MDs) in Europe (see previous network article). It replaces the former regulation (EU) 207/2012.
For Switzerland
In Switzerland, the provisions of the Ordinance on Medical Devices (Odim) already provided for the harmonization of Swiss medical device legislation with the new (EU) Medical Devices Regulation 2017/745.
In accordance with article 95 of Odim and with the revocation of regulation (EU) 207/2012, Switzerland now directly applies the implementing regulations (EU) 2021/2226 and (EU) 2025/1234 without further amendments to Odim.
Conclusion
This “immediate” harmonization with European Union requirements strengthens regulatory consistency between Switzerland and the EU, thus facilitating the compliance of medical devices.
Article written by Lam-Xé NOEL, Managing Director of DM Experts SAS