On 25 June 2025, the European Commission (EC) introduced a new regulation allowing electronic Instructions for Use (eIFU) for medical devices used by healthcare professionals within the European Union. This regulatory change removes the obligation for manufacturers to supply printed instructions, marking another step forward in the EU’s digital health transformation.
What’s Changing?
Under the new rule, healthcare professionals can now access device instructions in electronic format, rather than solely relying on paper leaflets. However, printed versions must still be available upon request to accommodate user preferences or specific clinical needs.
This simplification aligns with broader efforts to:
- Modernize healthcare systems across the EU
- Reduce environmental waste
- Lighten financial and administrative burdens for device manufacturers
The update received strong support from both the healthcare and medical device industries during recent consultations.
What’s Next?
This update is part of a wider initiative to streamline EU medical device regulations, which includes:
- Plans to establish an expert panel for devices intended for small patient populations (e.g. children or patients with a rare disease)
- An ongoing evaluation of the Medical Devices and IVDs regulatory framework to reduce regulatory burden while maintaining high safety standards
The Commission has announced that this evaluation and its follow up actions will be shared at a medical devices conference in Brussels this December.
Official Source: Commission simplifies instructions for use of medical devices to further digitalize healthcare systems
Published by European Commission on 25 June 2025
