Electronic Instructions for Use (e-IFU) for Medical Devices. Why it makes sense.

Medical device manufacturers are required to provide Instructions for Use (IFU) to ensure the safe use of their products. Today these instructions are commonly provided in printed format together with the medical device. In accordance with regulations (e.g. EU Regulation 207/2012 and FDA Blue Book), medical device instructions can be provided in digital format, for example via a website. This process is called electronic Instructions for Use (e-IFUs).

Digital instructions for medical devices make sense for two reasons:

  1. They are a more effective communication tool, leading to increased product safety and improved customer satisfaction
  2. When digital instructions replace printed instructions they allow manufacturers to simplify their processes and operate efficiently

Today customers expect instructions to be provided digitally via the internet. Forward looking manufacturers can leverage digital instructions to better meet customer expectations. Providing electronic instructions may allow customers to gain a better understanding of the product and ensures that they always have the instructions at hand. This leads to improved safety and outcome of the device application.

Replacing printed instructions through electronic instructions is possible for certain groups of medical devices. A common regulatory requirement for electronic instructions is that the device is exclusively used by professionals such as nurses or physicians.

Electronic instructions may also lead to reduced product cost and simplified operational and administrative processes. The cost of the printed instructions and the operational resources required to add these instructions to the product can be saved by using electronic instructions. On an administrative level the cost of sourcing, stocking and replenishing the instruction documents can be eliminated.

Most manufacturers today are exploring potential solutions to electronic instructions. However, many are hesitant to going completely digital until a common and established process is in place. Some medical device manufacturers are starting to use the concept of electronic instructions to not duplicate the paper instructions but to complement these through enhanced content such as video or interactive instructions.

Tomorrows best in class medical devices will be accompanied by electronic instructions which will allow customers to better understand the product and enable manufacturers to run improved operations. Already today a new wave of manufacturers on the marketplace exploring electronic instructions as a way of gaining a competitive advantage. Whether the objective is cost reduction, improved safety or better communication, medical device manufacturers should have a strategy for electronic instructions in place to maintain competitiveness and differentiation.

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