EC Clearing Path for Use of eIFU for Some Devices

Makers of some devices in the EU may soon be able to use electronic instructions for use (eIFU) in addition to paper instructions. The European Commission is working on legislation that would allow eIFU for some devices used by healthcare professionals, specifically fixed devices, ones with built-in display systems and implantable devices, including the tools required to implant them. Once the legislation is passed, makers of eligible devices could make their IFU available via DVD, CD-ROM, memory stick and on the internet, in addition to the paper format. Currently, IFU for devices marketed in the EU can only be disseminated in a paper form.
International Medical Device Regulatory Monitor