FAQ on the Imple­men­ting Regu­la­ti­on on elec­tro­nic ins­truc­tions for use (eIFU) for medi­cal devices

Updated on 21 July 2025

Imple­men­ting Regu­la­ti­on (EU) 2021/2226 lays down rules for the elec­tro­nic pro­vi­si­on of ins­truc­tions for use for medi­cal devices sin­ce Janu­ary 4, 2022. With Imple­men­ting Regu­la­ti­on (EU) 2025/1234 this was amen­ded on July 16, 2025, and the opti­on of elec­tro­nic ins­truc­tions for use was exten­ded to most medi­cal devices. Our FAQ ans­wers the most important questions.

What is the Imple­men­ting Regu­la­ti­on about?

On June 26, 2025, Imple­men­ting Regu­la­ti­on (EU) 2025/1234 was published in the Offi­ci­al Jour­nal of the EU. It amends the pre­vious regu­la­ti­on, which details the requi­re­ments for the elec­tro­nic pro­vi­si­on of ins­truc­tions for use (IFU) for medi­cal devices. The actu­al con­tent of ins­truc­tions for use is gover­ned Annex I, Chap­ter III, No. 23.4 of Regu­la­ti­on (EU) 2017/745.

Which pro­ducts are affec­ted by the Regulation?

Pre­vious­ly, under Artic­le 3(1) of Regu­la­ti­on (EU) 2021/2226, elec­tro­nic ins­truc­tions for use could only be pro­vi­ded in place of paper ins­truc­tions for cer­tain medi­cal devices, name­ly implan­ta­ble and acti­ve implan­ta­ble medi­cal devices, fixed instal­led medi­cal devices, and medi­cal devices fit­ted with a built-in sys­tem for dis­play­ing ins­truc­tions for use, as well as their access­ories. In addi­ti­on, the­re was a rest­ric­tion that the­se medi­cal devices or their access­ories were inten­ded exclu­si­ve­ly for use by pro­fes­sio­nal users.

With the ent­ry into force of the amend­ments, howe­ver, elec­tro­nic ins­truc­tions for use may be pro­vi­ded for all pro­ducts within the mea­ning of Artic­le 1(4) MDR. This covers all medi­cal devices and their access­ories, as well as the pro­ducts lis­ted in Annex XVI MDR, inso­far as they are inten­ded for use by pro­fes­sio­nal users. Pro­vi­si­on in paper form is then only requi­red if a pro­duct is reason­ab­ly expec­ted to be used by lay per­sons or is inten­ded for such use.

What are the objec­ti­ves of the Regulation?

The aim is to exploit the poten­ti­al of digi­ti­sa­ti­on, ensu­re pati­ent and user safe­ty and, at the same time, enable eco­lo­gi­cal and eco­no­mic bene­fits through paper­less docu­men­ta­ti­on. Sur­veys con­duc­ted by the Com­mis­si­on have shown that health­ca­re pro­fes­sio­nals pre­fer elec­tro­nic ins­truc­tions for use.

What con­di­ti­ons must be met for elec­tro­nic pro­vi­si­on of ins­truc­tions for use?

In accordance with Art. 4 of Regu­la­ti­on (EU) 2021/2226, a risk assess­ment by the manu­fac­tu­rer is still requi­red. Art. 5 spe­ci­fies the con­di­ti­ons that must be met for electronic-only pro­vi­si­on to be per­mit­ted. Among other things, the elec­tro­nic ins­truc­tions for use must:

• Be acces­si­ble free of char­ge at all times (in detail: Art. 5(9) and (10)),
• be regu­lar­ly updated and archived,
• be available in paper form on request.

How does the Regu­la­ti­on affect exis­ting processes?

Manu­fac­tu­r­ers must adapt their inter­nal pro­ces­ses – espe­ci­al­ly in tech­ni­cal docu­men­ta­ti­on, IT and qua­li­ty assu­rance. Sys­tems for ver­sio­ning, tracea­bi­li­ty and audi­ting of elec­tro­nic IFUs are beco­ming essential.

What are the tech­ni­cal requirements?

IT secu­ri­ty mea­su­res must be imple­men­ted to ensu­re the avai­la­bi­li­ty of con­tent even in the event of sys­tem fail­ures and to pro­tect against unaut­ho­ri­sed changes.

The refe­ren­ces to elec­tro­nic pro­vi­si­on must com­ply with Art. 6, and the web­site must com­ply with Art. 7 (2). As soon as pro­ducts have to be regis­tered in the UDI data­ba­se, the inter­net address whe­re the elec­tro­nic ins­truc­tions for use can be acces­sed must also be stored there.

What does this mean for user-friendliness?

The elec­tro­nic IFU must be intui­ti­ve for health­ca­re pro­fes­sio­nals to find and under­stand. Navi­ga­ti­on, lan­guage and pre­sen­ta­ti­on should sup­port safe use of the pro­duct – even in an emergency.

What are the dead­lines for implementation?

The chan­ges are bin­ding imme­dia­te­ly upon ent­ry into force; howe­ver, the pro­vi­si­on of elec­tro­nic ins­truc­tions for use is not mandatory.

What to do now?

Take the oppor­tu­ni­ty now to make your device com­mu­ni­ca­ti­on future-proof and digi­tal. Inves­t­ing in digi­tal user infor­ma­ti­on not only streng­thens your own com­pli­ance, but also the trust of users – and crea­tes a clear com­pe­ti­ti­ve advantage.

We are hap­py to assist you with any ques­ti­ons regar­ding the elec­tro­nic IFU for your medi­cal devices. Get in touch with us.