On 15th December 2021, the new Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use of Medical Devices (eIFU) has been published on the Official Journal of the European Union.
This Regulation repeals the previous Commission Regulation 207/2012 adapting to MDR (EU) 2017/745 requirements. However, the Commission Regulation (EU) 207/2012 still applies to devices already placed on the market or put into use during the transitional period, MDR, Article 120, section 3 (i.e., until 26th May 2024).
Electronic IFU Regulation for Medical Devices
The Implementing Regulation (EU) 2021/2226 outlines the circumstances in which the instructions for use (IFU) for Medical Devices can be presented in electronic format instead of paper format.
The European Commission decided to adopt this regulation in order to reduce the environmental burden and costs for Medical Devices industry, while maintaining or improving the level of security.
For which Medical Devices can instructions for use be provided in electronic format?
According to Regulation (EU) 2021/2226, Article 3, instructions for use may be provided in the electronic format for the following types of devices, covered by Regulation MDR (EU) 2017/745 and intended for professional use only:
- Implantable, and active implantable Medical Devices and associated accessories;
- fixed installed Medical Devices and associated accessories;
- Medical Devices and associated accessories with an integrated system for displaying instructions for use.
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.
Lastly, the Implementing Regulation requires that Manufacturers make instructions for use available in their websites by indicating on the devices label that IFU are provided in the electronic format instead of the paper one.
How to meet MDR requirements on the instructions for use?
We recommend downloading our White Paper “Medical Devices Labelling: instructions for use” to get an overview of IFU requirements required by MDR Regulation (EU) 2017/745. You can also contact us to ask for Thema experts assistance.
COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226 of 14th December 2021 laying down detailed rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of Medical Devices, Official Journal of European Union, December 15th, 2021