Medical devices need an efficient, effective, and readily available user manual. Over time, paper Instructions for Use (IFU) have been the norm in the medical device industry. However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU).
Though there are many advantages of using eIFU, complying with all the eIFU Regulatory requirements seems challenging. Global Regulatory Agencies outlined several rules that can be implemented. In recent times, the European Commission (EC) has issued certain rules that outline circumstances in which eIFU can be provided. Let’s decode them here.
EC eIFU Rules
The Commission Implementing Regulation has aligned the European Union (EU) with device regulators in the US, Australia, and the other nations that already allow electronic labeling/IFU for certain medical devices. As stated by the Commission Implementing Regulation, the provision of eIFU is beneficial for some medical devices, and it reduces the environmental burden and costs for the medical device industry while maintaining or improving the level of safety.
- The provision of eIFU will be allowed for fixed installed medical devices and their accessories, implantable and active implantable medical devices and their accessories, and medical devices and accessories fitted with a built-in system to visually display the IFU. For safety and efficacy reasons, users should always have the possibility to obtain those instructions for use in paper form upon request.
- To reduce potential risks as far as possible, the appropriateness of the provision of IFU in electronic form should be subject to a specific risk assessment by the manufacturer. The following elements are covered under the risk assessment:
- characteristics of the environment in which the device will be used
- knowledge and experience of the intended users and the use of the device and user needs
- knowledge and experience of the intended use of the hardware and software needed to display the IFU in electronic form
- user access to the reasonably foreseeable electronic resources needed at the time of use
- performance of safeguards to ensure that the electronic data and content are protected from tampering
- safety and backup mechanisms in the event of a hardware or software fault, particularly if the IFU in electronic form are integrated within the device
- foreseeable medical emergencies requiring the provision of information in paper form
- evaluation of the period within which the instructions for use shall be provided in paper form on the user’s request
- assessment of the website’s compatibility displaying the eIFU with different devices which could be used to display those instructions
- For devices with a defined expiry date (except implantable devices), the manufacturers should keep the eIFU available for ten (10) years after the last device has been placed on the market and at least two (02) years after the end of the expiry date of the last produced device.
- For devices without a defined expiry date and implantable devices, the manufacturers should keep the eIFU available for 15 years after the last device has been placed on the market.
- The IFU shall be available on their website in an official language of the Union determined by the Member State in which the device is made available to the user or patient.
- All issued historical electronic versions of the IFU shall be available on the website.
- Manufacturers shall clearly indicate on the label that the IFU of the device is supplied in electronic form instead of paper form.
- The eIFU form shall be available entirely as text, which may contain symbols and graphics, with at least the same information as the IFU in paper form. Video or audio files may be provided in addition to the text.
Henceforth, the manufacturers willing to place their devices on the European market must abide by the EC eIFU rules. Implementing these rules will enable much more flexibility and mitigate the chance of IFU-related product recalls. Are you working on your device labels and preparing the eIFU? Do you need an expert’s assistance? Reach out to Freyr.