On 26 June 2025, the Euro­pean Com­mis­sion adopt­ed imple­ment­ing reg­u­la­tion (EU) 2025/1234 allow­ing health­care pro­fes­sion­als across the EEA to access med­ical device instruc­tions for use (IFU) elec­tron­i­cal­ly rather than sole­ly on paper. 

The reg­u­la­tion will enter into force on July 16, 2025. The amend­ment to reg­u­la­tion (EU) 2021/2226 broad­ens the scope for eIFU to all med­ical devices that are intend­ed to be used by health­care pro­fes­sion­als. Where devices intend­ed for pro­fes­sion­al use may also be used by lay per­sons, such as patients, the IFU intend­ed for lay per­sons should be pro­vid­ed in paper form. 

The reg­u­la­tion can be found here.

Should you have any ques­tions or com­ments, please don’t hes­i­tate to get in touch.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website