These news are not brand-new, but they may nonethe­less become impor­tant for cer­tain man­u­fac­tur­ers of devices with a non-med­ical pur­pose. The Euro­pean Commission’s Sci­en­tif­ic Com­mit­tee on Health, Envi­ron­men­tal and Emerg­ing Risks (SCHEER) has tak­en a man­date for a sci­en­tif­ic opin­ion on brain stim­u­la­tors with­out a med­ical pur­pose. Cer­tain devices with­out a med­ical pur­pose, includ­ing brain stim­u­la­tors, are reg­u­lat­ed by the med­ical devices reg­u­la­tion (MDR), annex XVI.

Cur­rent­ly, brain stim­u­la­tors fall into class III fol­low­ing imple­ment­ing reg­u­la­tion (EU) 2022/2347. The new sci­en­tif­ic opin­ion will look at new sci­en­tif­ic evi­dence, which may result in a clas­si­fi­ca­tion change.

The com­plete request for sci­en­tif­ic opin­ion can be found on the Com­mis­sion web­site

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website