The regulation brings digital enablement to the forefront, compelling electronic instructions for use.
EU MDR is turning digitization on its head. This new regulation, which goes into effect May 26, 2020, is inducing digitization back to the forefront. EU MDR aim to enhance medical device safety and effectiveness and to realize this, the new regulation requires the use of eIFU.
eIFU: Meaningful Requirement Improving Patient Safety
European MDR makes eIFU a requirement while supercharging it with a meaningful value proposition. eIFU improves patient safety by providing users with the most up-to-date information in their preferred language. In addition, eIFU can include video and audio files, making it easy to demonstrate operating and handling instructions through mobile devices. And, time to market with revisions or changes is much faster via electronic distribution; ensuring users access the most accurate information.
Complying with eIFU Requirements
To comply with and exploit the benefits of eIFU, a manufacturer should primarily complete a documented risk assessment that demonstrates eIFU maintains or increases safety compared to traditional IFU. Some of the additional requirements include:
- Clearly specify on the product packaging of each unit that the instructions for use are provided in electronic rather than paper form. If it is a fixed medical device, this information should appear on the device itself.
- Provide eIFUs in a universally available format and include information on the hardware and software requirements required to display them.
- Develop alternate plan for users who do not have Internet access by providing a paper copy, upon request, of the IFU within seven days at no extra cost to the user.
- Ensure eIFUs are available for at least two years after the expiry date of the last produced device or 15 years after the last manufactured device in case of implantable devices or devices without a defined expiry date.
Compliance with EU MDR and eIFU need major process redesign for many manufacturers. Documented risk assessments and quality management systems are a must for eIFU. If a manufacturer is considering outsourcing its eIFU, it is the sole responsibility of the manufacturer to maintain safety over the products, including supplemental materials according to new European Medical Device Regulations.
Manufacturers must ensure the information user access is precise. This means having accurate product data in real time and a solution for delivering the information in the user’s preferred language.
As digital enablement will soon be a requirement under MDR, manufacturers need a system like VISU with a centralized product repository with access to global product information and web based eIFU multi language portal to manage IFU updation and distribution globally, enabling the promise of improved patient safety and engagement is within reach.