EC Draft Regulation for Electronic IFU

The European Commission (EC) has released a draft regulation that expands the device categories authorized to provide instructions for use in electronic form instead of paper instructions to include certain medical devices including SaMD.  Articles 3 and 5 describe the eligible devices and conditions where this is the case, while Articles 6 and 7 detail other labeling and electronic IFU requirements.  The regulation is in the feedback phase and Commission adoption is planned for the second quarter of 2021.

The draft basically lays out the process manufacturers must follow in order to maintain compliance during the transition. The decision to switch must include the use of a risk assessment, found in Article 4, to address any issues instructions for use in electronic form may bring as they relate to a specific product. The regulation points out that users must be able to obtain a paper copy upon request, as well as have access to the electronic IFU on the manufacturers website in the official language where the device is offered.  As would be expected, any content on the website and electronic IFU is still subject to the same requirements that exist for paper IFUs, to include Regulation (EU) 2017/745 and Regulation (EU) 2016/679.

Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices:

  • implantable and active implantable medical devices and their accessories covered by Regulation (EU) 2017/745
  • fixed installed medical devices covered by Regulation 2017/745
  • medical devices and their accessories covered by Regulation (EU) 2017/745 and fitted with a built-in system visually displaying the instructions for use

Keep in mind that the draft regulation appears to be limiting this provision of electronic IFU to professional users only.  Specifically the draft specifies the following conditions:

  • the devices and accessories are intended for exclusive use by professional users, and
  • the use by other persons is not reasonably foreseeable

For software covered by Regulation (EU) 2017/745, manufacturers may provide instructions for use in electronic form by means of the software itself instead of in paper form.

Devices not covered can be found in Annex XVI of Regulation (EU) 2017/745.

The draft can be found at https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12954-Medical-devices-online-manuals-replacing-paper-instructions_en

Upcoming SoftwareCPR Training Courses:

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  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
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