Implementing Regulation (EU) 2021/2226

Are you a manufacturer of a medical device? In that case, since January 2022 it has been possible under certain conditions to provide instructions for use exclusively in electronic form. The conditions under which this is possible can be found in Implementing Regulation (EU) 2021/2226.

In our knowledge base you will find more information about the conditions and requirements set in the regulation for electronic instructions for use (elFUs).