The EU’s MDR is bringing digital enablement to the forefront of the medical device industry. Compliance will require manufacturers to develop electronic instruction for use (eIFU) in an effort to improve patient safety and quality of outcomes. As a result, manufacturers are tasked with evolving existing business processes to meet the eIFU requirements.
Attend the MedTech Intelligence EU MDR series of workshops in-person or virtually2012 was a year of technological metamorphosis in both the consumer technology and medical device industries. Facebook went public with a $16 billion IPO, acquired mobile-only Instagram for $1 billion and set off a global frenzy of digital content sharing and consumption. Mobile’s future was further crystalized as technology companies spent billions acquiring and developing all things mobile in an effort to remain relevant. The frictionless movement of all things digital was underway—with the swipe of a finger, users were proving they could influence everything from global commerce to political theaters.
At the same time, in the medical device industry the European Commission (EC) passed regulation No. 207/2012 on electronic instruction for use (eIFU) of medical devices. This enabled manufacturers to replace paper instruction for use (IFU) with an electronic substitute. The goal of this modernized delivery system was clear: Reduce environmental burden; improve competitiveness within the industry by reducing costs; and maintain or improve patient safety. Similar regulations were previously passed in the United States in 2003 and in Europe in 2007, but the 2012 regulation was monumental because it mirrored the innovation happening in consumer technology by allowing video or audio files in addition to text.
Across both the tech and medical device industries, the outcomes were similar: Some organizations were eager to embrace new technologies and modernize their processes, while many were not yet ready to adopt a mobile- or digital-first mindset.
But the European Union’s MDR is turning this on its head. The regulation, which goes into effect May 26, 2020, is bringing digital enablement back to the forefront. The aim of MDR is to increase medical device safety and effectiveness and in order to accomplish this, the new regulation requires the use of eIFU.
Read Charlie Kim’s previous column, “Keep Calm and Carry On… And Other Outlooks We Can Apply to MDR Implementation”
Improving Patient Safety with Dynamic eIFU
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, speed 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 maximize the benefits of eIFU, a manufacturer must first complete a documented risk assessment that demonstrates eIFU maintains or increases safety compared to traditional IFU. Following this, additional requirements include:
- Clearly indicate on the product packaging of each unit that the instructions for use are supplied in electronic rather than paper form. In the case of fixed medical devices, this information must appear on the device itself.
- Provide eIFUs in a commonly available format and include information on the hardware and software requirements needed to display them. In addition, provide information on how to access the instructions for use in electronic form, such as through the addition of a URL.
- Create special website requirements, such as protection against hardware and software intrusions to minimize server downtime and display errors.
- Develop a contingency plan for users who do not have Internet access. This must include providing a paper copy, upon request, of the IFU within seven calendar days at no additional cost to the user.
- Ensure eIFUs are available for at least two years after the end of 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.
Process Design Considerations
Compliance with MDR and eIFU requires significant process redesign for many manufacturers. Documented risk assessments and quality management systems (QMS) are a must for eIFU. If a manufacturer is considering outsourcing its eIFU, their QMS must monitor, maintain and control the processes of the third-party as if they were internal. MDR states it is the sole responsibility of the manufacturer to maintain safety over the products they sell, including supplemental materials.
In addition, because user interaction is required to identify and request eIFU, manufacturers must ensure the information users access is correct. This means having accurate product data in real time and a solution for delivering the information in the user’s preferred language.
While the EC made digital enablement possible for the medical device industry nearly a decade ago, soon it will be a requirement under MDR. While this likely means rigorous process redesign for many manufacturers, the promise of improved patient safety and engagement is within reach.