How to transition to eIFU

For Medical and In vitro Diagnostic Devices.

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eIFU Requirements

Transitioning your organisation to eIFU consists of two components, the setup of an eIFU system and changing the device packaging / labelling.

Step 1

eIFU system setup

  • eIFU software specification documenting the functional, regulatory, quality, user interface requirements.
  • The development and validation of the eIFU software that meets the documented specifications.
  • The integration of eIFU data between your ERP/PMS and the eIFU system. For example: REF, GTIN, UDI, etc.
  • The computer system validation (CSV) of the entire eIFU system including software and processes.
STEP 2

eIFU change management

  • Creating an impact assessment in order to ensure the integrity of the packaging.
  • Defining the substitution options such as Patient Implant Cards.
  • Documenting the labelling changes in order to meet eIFU specifications.
  • Handling of the change management process.

Don’t worry, dokspot will handle it!

eifu system setup

A unique reference, giving direct access to the device instructions for use and other information

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.

eIFU system setup

eIFU is a digitization opportunity with a sustainability impact.

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.

Building an eIFU project team requires different functions of the business coming together

Regulatory Assurance
IT
Finance
Supply Chain
Marketing
Labelling
Quality Assurance

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 your partner in eIFU system setup and eIFU change management

dokspot is trusted by the worlds leading medical and in vitro diagnostics manufacturers to safely and securely deliver eIFU to customers globally.

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Excellence in eIFU software operation and maintenance

The 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.

Deep knowledge of quality control and compliance for eIFU

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.

Next steps

Match-making. Organise a non-binding call to review your eIFU needs and to determine if dokspot is a good fit.

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