Clear and accessible instructions for use are essential to ensure the safe and correct use of medical devices. While electronic instructions for use (eIFU) can offer important benefits, including more accessible formats, multiple languages and updated information, they should complement, not replace, paper instructions where these are already required.

A broad shift towards electronic-only instructions risks creating new barriers and inequalities. Patients, carers and healthcare professionals may need immediate access to essential safety information in situations where internet access, electricity or digital devices are unavailable. This could particularly affect older people, people with disabilities, people with limited digital skills and those living in rural or low-connectivity areas. Electronic-only information also raises concerns around privacy and could transfer additional responsibilities to patients and already overstretched healthcare professionals.

AIM, BEUC, CED, CPME, EFN, EAHP, EPF, HOPE and PGEU therefore call on EU co-legislators to ensure that the revision of the medical devices legislation preserves access to paper instructions for use, while ensuring that digital instructions remain accurate, accessible, privacy-protective, non-promotional and available in all required languages. Digitalisation should improve access to health information without creating new barriers, risks or responsibilities for those who rely on medical devices.