Implementing an eIFU-platform is a significant undertaking. But the potential benefits more than making up for this; IFUs can be made available on websites as stipulated in Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), and potential savings can be achieved if IFUs are no longer inserted into the packaging.
Implementing an eIFU-platform should always be in accordance with the requirements of your quality management system and applicable regulations.
A smooth implementation: tips and tricks
What are the key stages underpinning a successful eIFU implementation? Vital elements include customisation of the platform to meet specific needs, revamping product labels and IFUs for a polished presentation, streamlining operational procedures to boost efficiency, putting free phone support in place, and careful allocation of resources and responsibilities. Taken together, these can provide a firm foundation for eIFU rollouts.
One prerequisite is assuring potential customers that you are ready to provide the IFU in an electronic form instead of paper. If end users do not have easy access to internet to consult the eIFU platform, a rollout will not be suitable.
Regulatory considerations must be considered throughout the process. For IVDs like self-test, IFUs cannot be provided in electronic form instead of paper. Similarly, for MDs, it is only possible for a limited number of products to be used exclusively by professional users.
With these conditions met, a project charter may be drafted to systematically plan the rollout. Good practice is to conduct at an early-stage risk assessment from different perspectives. One is the end user; this means understanding their knowledge, experience and work environment, including emergency situations. Another is information technology, including access and availability to internet and protection from tampering. And taking into account manufacturer processes – for example errors introduced during uploading to the eIFU-platform – is essential.
Mitigating risks and ensuring success
To effectively mitigate risks, it is imperative to incorporate these actions into a comprehensive project plan. Doing so requires a multifaceted effort involving various departments.
Design and development teams will focus on tasks such as redesigning labels, including URLs and, if needed, free phone numbers and IFU updates. Marketing will play a crucial role in aligning the eIFU platform with the corporate identity and maintaining communication with customers. Regulatory Affairs will be responsible for updating Technical Documentation and liaising with relevant regulatory bodies. Quality Assurance will oversee revision and creation of documentation, encompassing risk assessments and verification or validation processes. Operations teams will optimise logistics processes for improved efficiency, HR will contribute through training initiatives, and IT departments will analyse eIFU platforms to ensure functionality and security.
This collaborative, cross-functional approach will ensure a comprehensive integration of risk mitigation actions into project plans.The project should be progressed to the point where the notified body can be provided with regular updates, if applicable. When approval has been obtained, the end-users is informed of the change and the implementation can be completed.
Once live, feedback from end-users should be acquired and recorded in the Quality Management System (QMS) and handled as post-market surveillance information. The latter offers input for reassessing the risks associated with the eIFU-platform.
Once established, the opportunity may be taken to further develop the eIFU-platform for other communications with end-users. This may include supply of Safety Data Sheets and Certificates of Analyses. Beyond this, eIFU may be expanded into new territories – extending the benefits to hitherto unexplored markets.
Getting a new eIFU platform online is no small task – but help is at hand. IFUcare has been helping trailblazing medical manufacturers revolutionise their IFU protocols for over a decade. Download the whitepaper on this page to find out how they can help you too.