In Europe, manufacturers of certain categories of medical devices (MDs), such as implantable MDs, and of in vitro diagnostic (IVD) devices for professional laboratory use, can replace the paper instructions for use (IFU) with an electronic version (eIFU). For MDs the conditions and requirements have been published in regulation 207/2012. For IVDs, a guidance document was published as MEDDEV 2.14/3 (2017).
Please note that eIFU embedded in software or built in an instrument are not in the scope of this article.
It is crucial for safety that users have access to the correct IFU when they need it. Therefore, it is logical that eIFU solutions are subject to strict requirements. Consequently, notified bodies (NB) will verify how a manufacturer has designed and implemented his eIFU solution in agreement with the requirements.
Manufacturing And Logistics
The complications and challenges for ensuring that each user has the correct paper IFU with the right product are well known to every manufacturer. IFU for MD and IVD typically have different versions, differing from each other because of language requirements, region or country specific regulatory requirements, batch-to-batch variation, etc.
Replacing paper IFU with an eIFU solution eliminates these difficulties, but the impacted procedures, work instructions, other QMS documents, and data in the enterprise resource planning (ERP) system — including the bill of materials — will have to be identified and modified to accommodate the new situation.
Management Of The Web Platform
Given the importance for users and patients to have the correct eIFU available, it is not only critical that the web platform itself is correctly designed, but adequate controls are also needed for managing the eIFU on the web platform.
To ensure the web platform is designed correctly and adequate controls are in place, procedures will have to be written, which address the following issues:
- Access to the system. An administrator and operators must be identified, and their respective rights and authorities defined.
- Instructions on how to perform actions such as adding and deleting eIFU.
- Defining which metadata to be used in searches, etc.
- Define archiving times.
Provision Of Paper Copies
For both MD and IVD the regulations stipulate that the user has the right to ask for a paper copy free of charge. Regulation 207/2012 for MD requires a paper copy to be available to the user within seven calendar days.
Purchasing Controls
Implementing eIFU may change the manufacturer's relationship with suppliers involved in the labeling process. Considerations include: Does the supplier have an understanding of software design requirements? Does the supplier have an ISO 13485 certified QMS? Which cybersecurity measures are in place? Is the supplier ISO 27001 certified?
Post-Market Surveillance (PMS) And Risk Management
Risk assessment is an important input in the design of an eIFU platform. It is a regulatory requirement to include the review of information from the market related to the eIFU in the PMS process.
Conclusion
The implementation of an eIFU solution has a significant impact on several QMS processes and will lead to the modification, creation, and deletion of procedures and instructions. A well-managed change process is required, but once this has been successfully completed, the manufacturer will benefit from the direct and indirect savings that an eIFU solution offers.
