Commission publishes draft amendment to (EU) 2021/2226 on eIFU

Currently, electronic Instructions for Use (eIFUs) are only allowed for certain types of medical device, e.g.:

• If they are for professional use and use by other persons is not foreseeable:
  • Implantable and active implantable devices,
  • Fixed installed medical devices and their accessories, and
  • Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use.
• For software covered by the Regulation, the instructions may be provided in electronic format by means of the software itself.

In August 2024 the Commission announced a survey to collect feedback from professional users on whether eIFUs should be allowed for all professional use medical devices. 87% of respondents responded positively.

The Commission has now published the draft amended eIFU regulation in which it is proposed to expand the allowance of eIFUs to all professional use medical devices, presuming they meet the other requirements under the regulation, e.g., to carry out a documented risk assessment; to have a mechanism to provide paper IFUs upon request, at no cost to the user, within 7 calendar days.

A public comment period is open until 21 March 2025. Publication of the amended regulation is apparently planned for Q2 2025.