Implementing a compliant solution for the electronic distribution of Instructions for Use

The regulations

The first objective of regulations is to ensure the safety of patients, users and other persons. Therefore, the electronic distribution of IFU is the subject of European regulations and guidance and is also regulated in other territories. Patient safety can only be guaranteed if eIFU are used in the right setting and under appropriate conditions. It is important to understand the regulatory framework in which eIFU can be used. In this article, the focus is put on the European eIFU regulations.

First of all, replacing the paper instructions by eIFU is not allowed for all MD and IVD. eIFUs are only accepted for devices to be used by a healthcare professional. All devices intended for lay people require a paper IFU to be supplied together with the product. For IVD used by healthcare professionals, eIFU can be provided instead of paper IFU, except for point-of-care devices. The regulators fear that the user in a point-of-care setting might not have easy access to the eIFU at the time of use of the IVD. Furthermore, special rules also apply for IVD instruments and software.

For MD, the regulations are even more restrictive. There are five clearly defined types of MD for which IFU can be made available online. These include: active implantable MD and their accessories, implantable MD and their accessories, fixed installed MD, MD and accessories with built-in system visually displaying IFU, stand-alone software. All others still require a paper copy to accompany the device.

Second, even with an electronic system in place to provide eIFU, some users may still want a paper copy of the IFU. Therefore, a compliant eIFU solution must also provide the users with a way to obtain a paper copy upon request. For IVDs, the manufacturer must provide a free telephone number which the user can call to request the paper IFU to be sent to him via mail, fax or email. For medical devices, the regulation does not specify how a copy must be provided. It does clearly state, though, that the paper version must be provided to the user within seven days from the request, and this without any charges to the user.

Third, uploading documents to a digital platform may appear quite straightforward, but the platform itself must comply with certain requirements as well. From a functional perspective, the website must work properly. Retrieving an IFU from the website should be self-explanatory in a language easily understood by the end-user. Access to the IFU should be quick and easy. The content of the instructions from the eIFU website, should be identical to the paper IFU and in a read-only format such as pdf. Moreover, the system must be secured and as such be hosted in an environment protected against hardware and software intrusion. This is also important to ensure permanent access to the website.

From a regulatory perspective, more restrictions apply to an eIFU platform. For instance, privacy regulations do not allow to capture personal data of the users downloading eIFU without their consent. However, regulations do not only restrict the use of eIFU. The new European MD and IVD Regulations clearly recognize the increasing importance of eIFU and state that the manufacturer has to make IFU available and keep them up to date on their website. This applies to all the devices, but except for the product groups described above, should be done in addition to the paper IFU accompanying the product. Manufacturers could consider meeting this requirement as an opportunity and first step to remove paper when possible, provided that they immediately use a web platform that meets the regulatory requirements for eIFU.

Impact on quality system

The decision to shift towards eIFU should not be made lightly. It has a significant impact on the manufacturer’s quality management system and will have to meet Notified Bodies’ expectations during audits.

A switch to the electronic distribution of IFU influences many quality system processes. The web platform itself will require full validation and the risk for patients and users has to be assessed. This risk assessment needs to focus on the risks associated with eIFU compared to paper versions, taking the use of the product, the environment of use and other end-user’s needs into consideration.

The implementation of an eIFU solution will have an impact on procedures and instructions in the management of eIFU and label content, the inventory management of labelling, the packaging process, logistical process, the ERP system and will trigger the creation of new procedures for the management of the web platform itself. Although this will initially take some effort, it will considerably reduce the work load of these processes. It will for example facilitate the process of introducing a new version of the IFU, since it will not impact the destruction and replacement of obsolete inventory. Paper IFU would require to be reprinted and if it concerns an immediate correction of an IFU boxes in stock must be reopened and IFU replaced. This is very labour-intensive compared to the electronic alternative.

Notified Bodies will verify whether the eIFU solution has been properly validated, whether risk assessment has been done, quality system processes and operational instructions have been adapted and labelling modified.

Impact on labelling

Manufacturers that use eIFU must inform the user on how to obtain the instructions for their products. It is recommended to do so via the product’s labelling.

Clear instructions must be provided on how to obtain the respective IFU, including a unique reference to identify the correct version of the document. This identifier has to be defined by the manufacturer and could be the reference number, UDI, GTIN or any other unique identification assigned to the product. As mentioned before, whenever the IFU have been revised, a clear indication must also be added to alert the customer that the document has been changed. Last but not least, a customer must be provided with the option to obtain the IFU on paper upon request as alternative for the eIFU. The necessary information on how to request that paper copy should be included on the label as well, or communicated by other means.

IFUcare’s solution

It clearly takes a significant effort to implement an electronic system for the distribution of IFU that complies with the different regulatory, functional and operational requirements. However, the investment will quickly create a return by savings in direct costs and by increasing the efficacy of the processes related to IFU management. The implementation of an eIFU solution becomes considerably less burdensome by working with a reliable supplier, who not only offers a ready-to-use, fully compliant eIFU solution, but who also understands the full context of an implementation project and provides the manufacturer the necessary support in e.g. validation, risk assessment, and labelling. With such a partner, the manufacturer is not alone and what first looked impossible, suddenly becomes a solution within reach.

IFUcare is the pioneer in eIFU and is still global leader. Its eIFU solution complies with all regulatory requirements and has all the functionalities that manufacturers expect built-in. IFUcare assists its customers by providing risk assessment and software validation documentation, by giving recommendations in handling labelling changes and notified body change requests, for example. IFUcare not only provides a platform, but also facilitates its implementation, reducing the manufacturer’s resource needs.

IFUcare was founded in 2000 to offer expert consultancy on IVD regulations and quality management systems. Based on this expertise, IFUcare’s first compliant eIFU solution was developed in 2008. Since then, it continuously improved to meet changing and new regulatory requirements and increasing customer demands.