On 21 February 2025, the European Commission published a public consultation on electronic instructions for use (eIFUs) for medical devices.
The consultation is open from 21 February 2025 until 21 March 2025. Stakeholders are invited to submit their feedback here.
Electronic IFUs for healthcare professionals
A survey conducted between August and October 2024 shows a clear preference, among healthcare professionals, for receiving instructions for use in electronic form rather than in paper. The proposed amendment highlights three important points:
- IFUs in electronic format for all medical devices and their accessories would be allowed only when the device is intended for exclusive use by healthcare professionals.
- For implantable medical devices and their accessories, part of the instructions for use intended to be provided to the patient shall not be provided in electronic form.
- With the mandatory use of EUDAMED manufacturers will provide the URL under which the electronic IFUs are persistently accessible.
Do you have questions on the current provisions for eIFUs for medical devices? Contact us here.
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