This Implementing Regulation establishes the conditions under which information in the instructions for use may be provided by manufacturers in electronic form, as referred to in MDR Annex I, Chapter III, point 23.1(f). This Regulation does not cover products listed in MDR Annex XVI. This regulation repeals Commission Regulation (EU) No 207/2012, however Commission Regulation (EU) No 207/2012 continues to apply to devices placed on the market or put into service during the transitional period set out in MDR Article 120(3).

Only for the following devices, manufacturers may provide instructions for use in electronic form instead of in paper form:

  • implantable and active implantable medical devices and their accessories covered.
  • fixed installed medical devices and their accessories.
  • medical devices and their accessories fitted with a built-in system visually displaying the instructions for use.

Manufacturers may provide instructions for use in electronic form instead of in paper form for the above listed devices only under the following conditions:

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

For software, manufacturers may provide instructions for use in electronic form by means of the software itself instead of in paper form.

What does this mean to you?

If you provide electronic instructions for use for MDR compliant devices, or you plan to provide electronic instructions for use in future when transitioning to the MDR, it is important to familiarise yourself with this new Implementing Regulation.

Should you want to discuss this more in depth with one of our consultants, or if you wish to learn more about the eIFU services offered by Qarad, please do not hesitate to get in touch with us

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