Regulations on electronic IFUs for EC-medical devices

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The European Commission issued a regulation on December 14, 2021 that allows the IFU to explain and implement medical device instructions in electronic form rather than paper form.

Under the enforcement regulations, the European Union will be able to manage the electronic usage guidelines in harmony with device regulators in the United States, Australia, and other countries.

 

Electronic IFU 

Electronic provision of IFUs to users applies to implantable and active implantable medical devices and their accessories equipped with built-in systems to visually indicate IFUs, as well as installation medical devices and their accessories, medical devices and accessories. Medical equipment and accessories should only be used for executive use, and the label of the device should be provided in electronic form, not IFU paper.

For some medical devices, it may be helpful to provide user instructions in electronic form instead of paper form.

It can reduce the environmental burden and reduce the cost of the medical device industry while maintaining or improving safety levels.

For the above reasons, the committee revealed the reasons for the enforcement regulations on IFU electronic provision.

 

Contents to be addressed when providing electronic IFU?

Providing IFUs electronically to reduce potential risks requires a manufacturer's specific risk assessment. Risk assessment should deal with several factors, including the contents below.
- Knowledge and experience of the intended user of the device and related hardware and software.
- Characteristics of the device usage environment.
- A protection device to protect electronic data from forgery.
- Backup mechanism in case of hardware or software malfunction
- A predictable, emergency medical situation that requires information in a paper format.
- Evaluation of the impact of temporarily unavailable websites or the Internet.
- Evaluation of the period in which instructions are provided in paper format at the request of the user.

 

Enforcement regulations require manufacturer-provided instructions for use and all past electronic versions to be available on the website.

In addition, there should be a system that clearly indicates when the IFU was revised and informs each user of the device if revision is needed for safety reasons.

 

For devices with a defined expiration date, the manufacturer must keep IFU available in electronic form for 10 years after the last device was released on the market and at least 2 years after the expiration date of the last produced device.

For implantable devices and devices without expiration dates, IFUs must be provided in electronic form for 15 years after the last device is released on the market.

 

More details can be found through the issued electronic IFU regulations for medical devices.

https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj

EUR-Lex - 32021R2226 - EN - EUR-Lex

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