European healthcare groups urge EU to retain paper medical device instructions

Nine European organizations representing patients, healthcare professionals, and medical services have issued a joint appeal to European Union co-legislators regarding the revision of the Medical Device Regulation (MDR). The groups, including Aim, Beuc, and Ced, are requesting that paper instructions for use remain mandatory in cases where they are currently required.

While the organizations do not oppose electronic instructions, they argue that digital formats should complement rather than replace paper versions. They expressed concerns that total digitalization could pose risks in situations involving stress, urgency, or vulnerability, where patients and caregivers may need immediate, offline access to instructions for assembly, application, or troubleshooting.

The signatories emphasize that manufacturers should be required to provide paper instructions upon request to ensure accessibility and safety, particularly for devices not intended solely for professional use.