Transitioning your organisation to eIFU consists of two components, the setup of an eIFU system and changing the device packaging / labelling.
The eIFU software maintains the integrity between device and instructions, it addresses global regulatory requirements and allows eIFU management of releases and languages for specific markets. Uploading instructions to a company website does not qualify as a regulation-compliant eIFU system, nor does it provide the same convenience as a paper-based IFU shipped with the product. Instead, eIFU must have “a unique reference, giving direct access, and any other information needed by the user to identify and access the appropriate instructions for use.” In other words, the end-users must have a linear path of accessing the eIFU without having to search online and decide which eIFU is the right one.
Device packaging and labelling changes fall into regular change projects of a medical device manufacturer. This means that the necessary QA process and documentation know-how is available and the change management team can draw from past experiences. When removing the paper IFU from the device packaging the packaging validation is reviewed, packaging is adapted if needed, and the labelling is updated to indicate eIFU.
Uploading instructions to a company website does not qualify as a regulation-compliant eIFU system, nor does it provide the same security and user convenience as a paper-based IFU shipped with the product. Instead, the eIFU must have a unique reference, giving direct access, and any other information needed by the user to identify and access the appropriate instructions for use.
In other words, the end-users must have a linear path of accessing the eIFU without having to search online and decide which eIFU is the right one. To satisfy the regulatory requirement, the product packaging must contain a unique code or identifier that leads to the product eIFU. Then, the only decision made by the user is to select the appropriate language.
dokspot is trusted by the worlds leading medical and in vitro diagnostics manufacturers to safely and securely deliver eIFU to customers globally.
Contact UsThe digital world changes fast and eIFU software requires constant attention and control. Internal IT experts move on, leaving organizations with know-how gaps leading to constantly recurring costs. The dokspot focus is on eIFU. We have a team of dedicated experts with a sole task: keeping your eIFU website compliant and available.
Breaking down regulatory and quality requirements into user interfaces and software functions is a design process that requires specific know how. dokspot has this knowledge. The dokspot eIFU service includes the regulatory and quality requirements and is built considering the requirements of leading medical device manufacturers.
dokspot GmbH
Freudenbergstrasse 101
8044 Zurich
Switzerland