EC outlines rules for electronic IFU for med devices

Regulatory NewsRegulatory News | 16 December 2021 |  By 

The European Commission has issued rules outlining the circumstances in which medical device instructions for use (IFU) can be provided in electronic form, rather than in paper form.
The implementing regulation, issued on 14 December, brings the European Union into alignment with device regulators in the US, Australia, and other nations, which already allow electronic labeling/IFU for certain medical devices. (RELATED: TGA Offers Guidance on Electronic Instructions for Use, Regulatory Focus 15 August 2018)
The electronic provision of IFU will be allowed for implantable and active implantable medical devices and their accessories, fixed installed medical devices and their accessories, and medical devices and accessories fitted with a built-in system to visually display the IFU. Devices and accessories must be intended exclusively for professional use. The device’s label should indicate that the IFU are supplied in electronic, rather than paper, form.
“For some medical devices, the provision of instructions for use in electronic form instead of in paper form can be beneficial,” officials wrote in the Commission Implementing Regulation. “It can reduce the environmental burden and reduce costs for the medical device industry while maintaining or improving the level of safety.”
To reduce any potential safety risks, moving the IFU to 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 the 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 from tampering
  • backup mechanisms in the event of hardware or software malfunction
  • foreseeable medical emergency situations requiring a paper form of the information
  • impact caused by the website or the Internet being temporarily unavailable
  • evaluation of the time period in which instructions will be provided in paper form at the user’s request
The implementing regulation also requires manufacturers to make the instructions, and all historical electronic versions, available on their websites. They must also have a system in place to clearly indicate when the IFU have been revised and to inform each user of the device if the revision was necessary for safety reasons.
For devices with a defined expiration date, the 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 produced device. In the case of implantable devices and devices without an expiration date, the IFU should be available in electronic form for 15 years after the last device has been placed on the market.
Implementing Regulation


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