IFUcare's journey started in 2007, coinciding with the publication of MEDDEV 2.14/3. Qarad, founder of IFUcare, was then a two-man IVD consulting company. The creation of eIFU services was catalysed by a customer request: explore the options to step away from paper and shift towards electronic instructions for use.
Six months later, in early 2008, this resulted in IFUcare's first-generation eIFU SaaS platform, supported by a Freephone service still used today and extended worldwide. 15 years later, these early adopters remain satisfied customers.
Adapting to regulatory shifts
In 2012 the EU 207/2012 (MDD) expanded eIFUs to certain classes of medical devices. The publication of MDR (EU 2017/745) and IVDR (EU 2017/746) in 2017 required all manufacturers with a web presence to provide IFUs electronically.
The situation today
In 2021, the EU 2021/2226 regulation shifted focus from providing information to ensuring users are kept up to date with updates. IFUcare supports these new processes automatically through the platform, alleviating the workload from manufacturers.
