Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A new Implementing Regulation explains how these apply under the Medical Device Regulation.
European Commissioner for Health and Food Safety Stella Kyriakides is calling on EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.
The possibility of providing instructions for use in electronic form instead of paper should be limited to certain medical devices and accessories intended to be used under specific conditions, the document states.
“For reasons of safety and efficiency,” it notes, “users should always have the possibility to obtain those instructions for use in paper form upon request.” The document also lays out rules for eIFU information made available on manufacturers’ websites.