The European Commission issued Regulation (EU) 2021/2226 that determines rules for the application of Regulation (EU) 2017/745 with regard to electronic instructions for the use of medical devices. The regulation was published in the Official Journal of the European Union on December 15, 2021 and became effective in early January 2022.

According to the regulation, there is a list of categories of medical devices that can have electronic instructions instead of paper ones. The list includes:

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

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Electronic instructions for the above-mentioned categories of the devices are applicable, if the devices and accessories are intended for the use by professional users only.

Electronic instructions instead of in paper ones can also be applicable for software covered by Regulation (EU) 2017/745.

At the same time, manufacturers must indicate on the labels that the instructions are supplied only in electronic form and should inform how to get access to the them.

Moreover, that part of the instructions for use which is intended to be provided to the patient, must be available in paper form.

Please, note that when the instruction is provided in electronic form, it should be accessible to the users through a website as well. 

The Regulation (EU) 2021/2226 repeals Commission Regulation (EU) No 207/2012. However, it is noted that the Regulation (EU) No 207/2012 still can be used for devices placed on the market or put into service until May 26, 2024.

The official text of the Regulation (EU) 2021/2226 you can find here.

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The information has been prepared by the GMA Consult Group team.‍

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