EU Opens Consultation on Draft Legislation for Electronic IFUs

By Dasun Abey and Evangeline Loh

The European Commission (EC) opened a four-week consultation on draft legislation allowing electronic Instructions for Use (eIFU) for medical devices used by professional users. Here’s what medical device manufacturers need to know about the proposed legislation.

Implementing Regulation 2021/2226 was intended to generally continue to advance Regulation 207/2012 on eIFU as devices (Article 3) that could be supplied with eIFUs were the same. Only a limited number of devices were considered within the scope of the legislation.

Healthcare professionals prefer eIFUs

In August-October 2024, the EC surveyed healthcare professionals about their preferences for eIFUs. The results: a “clear preference” for eIFUs (Recital 2 draft legislation).

Draft consultation

The EC released (February 21, 2025) an open consultation (Draft implementing regulation – Ares (2025)1431476) which proposes to revise Regulation 2021/2226. Interested parties have until March 21 2025 to respond.

Article 3(1) is revised to delete the explicit devices and expand eIFUs for medical devices “intended for use by professional users”. Article 7(3) is inserted to require the Uniform Resource Locator (URL) for the eIFU in EUDAMED when the device module in EUDAMED becomes mandatory.

Comments posted

In general, the comments supported eIFUs.

Concluding remarks

Medical device manufacturers generally favor eIFUs for their benefits: facilitates maintenance of the IFU, diminished physical resources (paper reduction, shipping), and as stated by professionals “helps the health sector deliver better and faster solutions”. 

This legislation signals a welcome step forward for industry as the majority of manufacturers and healthcare professionals feel the benefits are tremendous.