8 August 2025
Swissmedic: Implementation of EU Commission Implementing Regulation 2025/1234
Swissmedic has adopted the EU Commission Implementing Regulation (EU) 2025/1234 on instructions for use in electronic form with immediate effect. This Regulation has been in force in the EU since 16 July 2025 and extends the permissible scope of electronic instructions for professional users.
For devices intended for professional use, electronic instructions are now permitted for all medical devices and their accessories, as well as for products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 on medical devices (EU MDR), and for legacy devices. However, instructions for devices intended for lay persons must still be provided in paper form.
For more information, see here.
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