IFUcare: its history, evolution of eIFU regulations and the road ahead

IFUcare’s journey started way back in 2007. Its inception coincided with the publication of MEDDEV. 2.14/3 rev.1, a guidance document for the provision of IFUs for IVDs. Qarad, founder of IFUcare, was then a two-man IVD Regulatory and Quality consulting company founded by Dirk Stynen. The creation of the company’s eIFU services was catalysed by a seemingly simple customer request: explore the options to step away from paper and shift towards electronic instructions for use.

But it proved trickier than originally anticipated, with hurdles faced by individual manufacturers leading to disappointing results. Two main blockages became apparent: the creation of a system to host the IFUs as well as the need for surrounding support, and the provision to request paper copies free of charge. Qarad pioneered a novel approach: devise a new setup that could be used across multiple manufacturers.

Six months later, in early 2008, this resulted in IFUcare’s first-generation eIFU SaaS platform. The platform was supported by a Freephone service – one that is still used today and has been extended worldwide. Over these first couple of years, the eIFU service signed up the industry’s early adapters, aided by regulatory support provided by the growing team. 15 years later, these early adopters remain satisfied customers; they are still going strong in IFUcare’s latest 4^th generation system.

Adapting to regulatory shifts

In 2012 the EU 207/2012 (MDD) was published, which expanded eIFUs to certain classes of medical devices. While this brought challenges, it also created huge opportunities and resulted in the creation of a focused eIFU team – accelerating IFUcare’s growth and fostering an ambition to become the industry leader in both IVD and MD markets. Over the next couple of years, Qarad grew from a company supporting local Belgian firms to having a presence across the globe – ranging from start-ups to the leading brands in the industry.

The publication of MDR (EU 2017/745) and IVDR (EU 2017/746) in 2017 was another significant moment for the industry. All manufacturers with a web presence were required to provide their IFUs in electronic format. This event created a milestone for IFUcare; manufacturers, even if they were unable to remove paper copies themselves, began using the services solely for regulatory compliance.

The situation today – and looking ahead

In 2021, the EU 2021/2226 regulation was published, adding a new dimension to eIFU provision. The focus shifted from providing consumers with information to ensuring that they are kept up to date with newly issued updates. It means manufacturers are faced with sending updates every time an update is performed to any of the documentation. IFUcare has stepped into the breach, supporting the new processes automatically through the platform and alleviating the workload from the manufacturers.

What the next years will bring is a big question mark, though IFUcare is confident about its industry-leading team’s ability to tackle whatever arises. The platform’s main goal remains the same: provide a solution that brings ease of mind to customers by providing a compliant system in an ever-changing regulatory environment. To find out how partnering with IFUcare can help bring your regulatory compliance into the 21^st century, download the whitepaper on this page.