Tuttlingen – The EU Commission has published the draft for an implementing regulation on the use of electronic instructions for use (eIFU) for medical devices for comment. MedicalMountains GmbH advocates further opening up in the professional environment.
The planned implementing act is intended to replace the previously applicable Regulation (EU) No. 207/2012 on electronic instructions for use for medical devices. The draft envisages that for software falling under Regulation (EU) 2017/745, manufacturers can provide the instructions for use in electronic form with the software itself instead of in paper form. However, for products that have been or will be placed on the market on the basis of Article 120 (3) EU-MDR, the old regulation should continue to apply until May 26, 2024.
"The minimal expansion for the software area is very disappointing in view of the discussions that have been going on since 2019," says MedicalMountains Managing Director Julia Steckeler. "There are a number of plausible reasons for allowing the introduction and use of electronic instructions for use for other medical devices as well." It is explicitly only about products that are intended for use by professionals. For example, simple reusable surgical instruments for a range of surgical procedures: "Most of the companies in our network manufacture established medical devices with a long clinical history," Julia Steckeler recalls. “Nevertheless, instructions for use in paper form must be enclosed with everyone. This is no longer up-to-date in a professional environment such as in clinics.”
MedicalMountains GmbH will use the public consultation to advocate for a corresponding expansion of the possible uses of eIFUs. The submission deadline is Tuesday. Anyone who supports the cause is welcome to contact MedicalMountains GmbH. “On the other hand, it is not only associations or organizations that are heard. Every company, every EU citizen has the right to comment on the draft,” Julia Steckeler encourages people to enter their views and arguments directly on the EU website.
Positions on the planned implementing act can be submitted by email to steckeler@medicalmountains.de by Friday evening or entered on the EU website using this link. The draft can also be viewed there.
