Implementing Regulation (EU) 2025/1234 - Electronic Instructions for Use for Medical Devices
Amends Implementing Regulation 2021/2226 to update requirements for electronic instructions for use for medical devices. Modernizes documentation and accessibility standards for device instructions.
📅 Effective / published: 2025
Manufacturers and sponsors placing medical devices on the the EU market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗