In Europe, manufacturers of certain categories of medical devices (MD), such as implantable MD, 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 MD the conditions and requirements have been published in Regulation 207/2012. For IVD, 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.
In earlier blog contributions, we have written about the design requirements of an eIFU platform and on notified body expectations. In this article, we focus on the impact of the implementation of an eIFU solution on various processes in the quality management system (QMS).
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. Essentially, manufacturers have to decide whether they put multiple versions in one package during the packaging process, simplifying the logistics process, or add the right version at the time of shipping when the destination of the product is known. The former solution is often difficult or impossible because of the small packaging size. The latter complicates the preparation for shipping.
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. Depending on how paper IFU used to be added to the product, instructions for packaging and/or shipping will have to be revised. For example, instructions for in-house printing or for ordering IFU from a print shop may no longer be needed.
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. Note that eIFU have to remain available on the website for at least two years after the expiration date or for at least 15 years after last device has been manufactured in case there is no expiration date and also for all implantable MD.
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. For IVD, the MEDDEV guidance does not specify the time but explicitly asks that the manufacturer provides a free telephone number that users can call to ask for a paper copy.
For more than a decade, we have offered a full outsourced eIFU solution to manufacturers, and we have had relatively few requests for paper copies. Nevertheless, they do occur and the manufacturer must control the process from request to delivery and have the necessary procedure(s) in place.
Implementing eIFU may change the manufacturer’s relationship with suppliers involved in the labeling process. Maybe the print shop is no longer necessary or has become less critical.
On the other hand, manufacturers have the possibility of outsourcing their eIFU solution or parts thereof. The supplier of such a solution is a critical supplier and the selection process will be reviewed as such by the notified body. Considerations that should be taken into account include:
- Does the supplier have an understanding of software design requirements in the medical context, e.g., the EN/IEC 62304 standard?
- Does the supplier have an ISO 13485 certified QMS?
- Which cybersecurity measures has he in place?
- Is the supplier ISO 27001 certified?
- Does the supplier have relevant experience with MD and IVD and with eIFU in general?
The manufacturer will have to justify the choice for his supplier.
Postmarket Surveillance (PMS) and Risk Management
Risk assessment in general is an important input in the design of an eIFU platform and the supporting processes. Just like the context of device design and certification, risk management is a continuous process for the eIFU solution as well. It is a regulatory requirement to include the review of information from the market related to the eIFU in the PMS process, to assess the impact on the risk evaluation, and if appropriate, define risk mitigating actions.
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.