The Euro­pean Com­mis­sion has announced the devel­op­ment of sev­er­al imple­ment­ing reg­u­la­tions in 2025. These may be seen as short-term ini­tia­tives to cor­re­spond to the calls for changes by Par­lia­ment in 2024.

For the sec­ond quar­ter of 2025, the Com­mis­sion plans to pub­lish an imple­ment­ing reg­u­la­tion that would allow for the gen­er­al use of elec­tron­ic instruc­tions for use (eIFU) that are exclu­sive­ly intend­ed for pro­fes­sion­al use. The ini­tia­tive can be accessed here.

Also, for the sec­ond quar­ter, it is planned to estab­lish an expert pan­el for orphan and pedi­atric devices. The ini­tia­tive can be accessed here.

For the fourth quar­ter of 2025, the Com­mis­sion plans an imple­ment­ing reg­u­la­tion for the reclas­si­fi­ca­tion of well-estab­lished tech­nolo­gies under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). The Com­mis­sion aims to reclas­si­fy cer­tain well-estab­lished tech­nolo­gies in accor­dance with the devices’ nature and respec­tive risks. The ini­tia­tive can be accessed here.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website