The evolution of the European regulatory framework is opening up new opportunities for the use of electronic Instructions for Use for medical devices.
But beware! Adopting an e-IFU does not simply mean replacing a paper document with an online PDF.
Moving to an electronic format entails specific conditions, requirements and responsibilities for the Manufacturer: from risk assessment and website management to ensuring the availability of information and appropriate access to the Instructions for Use.
SCF has prepared a FOCUS to explore the relevant regulatory framework and the key aspects to consider when adopting e-IFUs.
