elFU rules under the EU‘s MDR

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The European Commission has published a new implementing regulation (EU) 2021/2026 outlining rules concerning the use of electronic instructions for use (elFU) in the context of Regulation (EU) 2017/745 on medical devices (MDR). It took effect from 3 January 2022 and replaces earlier elFU rules (EU) 207/2012 agreed to in the context of the former medical device directives.

Under the new implementing regulation, manufacturers can offer eIFUs in place of instructions in paper form for the following devices under the MDR:

  1. Implantable and active implantable medical devices and their accessories;
  2. Fixed installation medical devices and their accessories; and
  3. Medical devices and their accessories equipped with a built-in system visually showing the IFU.

The new text also clarifies how a risk assessment should be organised and kept updated so that it safe to provide IFU electronically. There should be a review of:

  1. Characteristics of the environment in which the device will be used;
  2. Predictable medical emergency circumstances necessitating the supply of information in paper form; and
  3. Performance of safety measures to guarantee that the electronic data and content are safeguarded from manipulation.

It also explains further considerations a manufacturer should make to provide eIFU’s. For example, any website including eIFUs must be protected against illicit access and interfering of data and set up so that the server downtime and display faults are considerably lessened. 

This new implementing regulation will apply under the MDR whereas the previous rules are still valid for legacy devices.

Source: Medtech Insight (an Informa product), European Commission

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