Rules for electronic instructions for use for medical devices
In the beginning of this year European Commission (EC) published a new implementing Regulation (EU) 2021/2026 outlining rules concerning the use of electronic instructions for use (elFU) in the context of Regulation (EU) 2017/745 on medical devices (MDR). Implementing Regulation 2021/2026 replaces earlier elFU rules (EU) 207/2012 agreed to in the context of the former medical device Directives.
For some medical devices, the benefits of eIFUs are significant:
- reduced environmental burden and costs for the medical device industry while maintaining or improving the level of safety;
- quicker updates and improvements to IFUs;
- less likely to have outdated IFUs in distribution chain;
- more use of video and animation that can explain device operation far more clearly than written instructions and photos.
The implementing Regulation brings the European Union into alignment with device regulators in the United States, Australia, and other nations, which already allow electronic labelling and/or IFU for certain medical devices. Manufacturers of medical devices can now offer eIFUs in place of instructions in paper form for the following devices under the MDR:
- implantable and active implantable medical devices and their accessories;
- fixed installation medical devices and their accessories and;
- medical devices and their accessories equipped with a built-in system visually showing the IFU.
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.
On the other hand, with regards to software covered by MDR, manufacturers can provide the instructions for use in the electronic format directly via the software itself.
Implementing regulation also explains further considerations a manufacturer should make to provide eIFUs. For example, any website including eIFUs must be protected against illicit access and interfering of data and set up so that the server downtime and display faults are considerably lessened. Manufacturers should make available all historical electronic versions on their websites, 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 medical 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 medical devices without an expiration date, the IFU should be available in electronic form for 15 years after the last medical device has been placed on the market.
This new implementing regulation will apply under the MDR whereas the Commission Regulation (EU) 207/2012 still applies to devices already placed on the market or put into use during the transitional period until 26th May 2024 (MDR, Article 120, section 3).