In the EU the distribution of information for the use of medical products is clearly regulated: For each product a printed IFU must be provided. Only under certain conditions – e.g. when products are implantable or permanently installed - the provision in electronic form is permitted (in accordance with EU Regulation 2021/2226).
Nevertheless, eIFUs are becoming increasingly important:
- User-friendly: Digital IFUs can be searched, enlarged or adapted in terms of language. In professional use, they offer quick access - e.g. via QR code.
- Up-to-date: The information provided can be updated quickly.
- Sustainability: By dispensing with paper, resources can be conserved, and packaging can be designed more efficiently.
- Global perspective: In countries such as the USA, Canada and Australia, eIFUs are already common practice for many medical products.
What is currently permitted?
According to EU regulations, eIFUs may currently only be used for certain medical devices, e.g:
- implantable or active implantable devices,
- permanently installed medical devices,
- products with an integrated display interface,
- and certain software.
However, on request a printed copy must be provided free of charge.
Do you have questions about this? Please contact us for more information!
Author: Healthcare Heads GmbH
Phone: +49 431 800 1470
E-Mail: info@healthcareheads.com