EC sets the rules for electronic IFU for medical devices

The European Commission has published rules outlining the circumstances under which instructions for the use of medical devices (IFUs) can be provided in electronic form rather than in paper form.

Implementation regulation, released on December 14, aligns the European Union with device regulators in the United States, Australia and other countries, which already allow electronic / IFU labeling for certain medical devices. (RELATED: TGA offers advice on electronic operating instructions, Regulatory guidance August 15, 2018)

Electronic supply of IFUs will be permitted for active implantable and implantable medical devices and their accessories, fixed installed medical devices and their accessories, and medical devices and accessories equipped with an integrated system to visually display the IFU. The devices and accessories must be exclusively intended for professional use. The device label should indicate that the instructions for use are provided in electronic form rather than on paper.

“For some medical devices, providing instructions for use in electronic form instead of paper form may be beneficial,” officials wrote in the Commission’s implementing regulation. “This can reduce the environmental burden and costs for the medical device industry while maintaining or improving the level of safety. “

To reduce potential safety risks, the passage of the operating instructions in electronic form should be subject to a specific risk assessment by the manufacturer. The risk assessment should cover several elements, including:

• knowledge and experience of intended users of the device and associated hardware and software
• characteristics of the environment in which the device will be used
• safeguards to protect electronic data against tampering
• safeguard mechanisms in the event of hardware or software malfunction
• foreseeable medical emergencies requiring a paper form of information
• impact caused by the temporary downtime of the website or internet
• assessment of the time within which the instructions will be provided in paper form at the user’s request

The implementing regulations also require manufacturers to make the instructions, and all historical electronic versions, available on their websites. They should also have a system to clearly indicate when the operating instructions have been revised and to inform each user of the device if the revision is necessary for safety reasons.

For devices with a defined expiration date, manufacturers should keep the IFU available in electronic form for 10 years after the last device has been placed on the market and at least two years after the end of the expiration date of the last one. device produced. In the case of implantable devices and devices without an expiration date, the instructions for use must be available in electronic form for 15 years after the last device has been placed on the market.

Execution regulations