Swissmedic: Adoption of EU Regulation 2025/1234 on use of Electronical Instructions for Medical Devices
On 26 June 2025, Implementing Regulation (EU) 2025/1234 was published in the Official Journal of the EU, entering into force on 16 July 2025. It amends Implementing Regulation (EU) 2021/2226, which sets out the requirements for the electronic provision of instructions for use for medical devices. The regulations have been expanded. Switzerland is adopting these requirements immediately, initially without any additional amendments to the Swiss MepV (Medical Devices Ordinance).
In brief:
- Products intended for professional users now have an extended scope of application for electronic instructions for use, covering all medical devices and their accessories.
- Products without a medical purpose, according to Annex XVI of the EU MDR, and 'legacy devices' are also subject to an extended scope of application if they are intended for use by professional users.
- Products used by lay persons still require instructions in paper form.
Regulation (EU) No 207/2012 of 9 March 2012, listed in Annex I of the EU MDR, is hereby repealed.
Source:
Swissmedic: News & Updates
EU: Implementing Regulation (EU) 2025/1234
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